Home » Trials » SLCTR/2021/036


Randomized clinical trial of the use of dexmedetomidine VS propofol for conscious sedation for arthroscopic shoulder surgery under interscalene block in beach chair position.

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SLCTR Registration Number

SLCTR/2021/036


Date of Registration

17 Dec 2021

The date of last modification

Dec 17, 2021



Application Summary


Scientific Title of Trial

Randomized clinical trial of the use of dexmedetomidine VS propofol for conscious sedation for arthroscopic shoulder surgery under interscalene block in beach chair position.


Public Title of Trial

A randomized controlled trial on the safety and efficacy of dexmedetomidine compared to propofol among patients undergoing arthroscopic shoulder surgery under conscious sedation and regional anaesthesia in the beach chair position


Disease or Health Condition(s) Studied

Conscious sedation and regional anaesthesia for arthroscopic shoulder surgery in beach chair position


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1267-5614


Any other number(s) assigned to the trial and issuing authority

ERC/2020/79 (Ethics Review Committee, Rajarata University


Trial Details


What is the research question being addressed?

What are the safety and efficacy outcomes of dexmedetomidine compared to propofol for conscious sedation for arthroscopic shoulder surgery under interscalene block in beach chair position?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded : Participants, Data analysts, Outcome assessors


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 3


Intervention(s) planned

Study setting The study will be set in the Teaching Hospital Anuradhapura, Sri Lanka. Surgical operations theatre.

Randomization A computer-generated randomization list was created through Microsoft Excel 2019 with 1:1 allocation in to 2 arms (Dexmedetomidine and Propofol arm) using block sizes 2 and 4 by an independent doctor who marked the questionnaire Dexmedetomidine or Propofol and put into the corresponding numbered sealed envelope. Allocation sequence was concealed from the investigator. All consenting patients are numbered consecutively and assigned the matching envelope

Arm 1 Propofol group- received Intravenous Propofol infusion through a cannula inserted to the non-operating hand. It is started after successful interscalene block and is continued till wound closure. Infusion is started at 1- 4 mg/kg/hour titrated to achieve a Modified Observer Assessment of Alertness/Sedation score of 3 or 4 (the MOAA/S ranges from 0 to 5, with a score of 5 defined as awake or minimally sedated, and a score of 0 defined as general anaesthesia with 4 being lethargic response to name spoken and 3 - responds after name called loudly/repeatedly).

Arm 2 Dexmedetomidine group- received intravenous Dexmedetomidine infusion through a cannula inserted to the non-operating hand, which started after successful interscalene block and is continued till wound closure. Started at 1 micrograms/kg loading dose over 10 minutes, followed by an infusion of 0.2- 0.7 micrograms /kg/hour titrated to achieve a Modified Observer Assessment of Alertness/Sedation score (MOAA/S) of 3 or 4 (the MOAA/S ranges from 0 to 5, with a score of 5 defined as awake or minimally sedated, and a score of 0 defined as general anaesthesia with 4 being lethargic response to name spoken and 3 - responds after name called loudly/repeatedly).

Standard care available to both groups

Patients were subjected to fasting according to guidelines as per general anaesthesia (fasting for solids and semisolids for 6 hours prior to surgery, fasting for clear fluids for 2 hours prior to surgery). On arrival to the operation theatre, standard monitoring, including, electrocardiography (ECG), non-invasive blood pressure (NIBP), and pulse oximetry were applied and baseline mean arterial pressure (MAP), heart rate (HR), peripheral oxygen saturation (SpO2), Respiratory rate (RR) and diaphragmatic excursion measured by ultrasound scan (Diaphragm excursion was measured using a phased array probe, with the probe positioned in the subcostal margin in the mid-clavicular line, with the aim of imaging the posterior third of the diaphragm and with the use of M-mode, accurate measurement of diaphragmatic displacement over a respiratory cycle was recorded). The interscalene block (ISB) was performed by the investigators themselves who are experienced with attending regional nerve block workshops and performing more than 100 interscalene brachial plexus blocks. All nerve blocks were performed adhering to the standard guidelines and following the universal precautions. Following successful block patients were subjected to full standard monitoring during surgery. Patient’s vitals (Respiratory rate-RR, Heart rate-HR, Systolic blood pressure-SBP, Mean arterial blood pressure-MAP) were monitored every 15 minutes by the anaesthetist taking care of the patient. Patients were monitored for hypotension (MAP decrease by 20% from baseline) or bradycardia (HR decrease by 20% from baseline). If severe symptomatic hypotension is found intraoperatively, it is treated with 5 to 10 mg IV ephedrine or fluid bolus (30ml/Kg 0.9% saline) and severe bradycardia with 0.5 mg IV atropine. Patients are observed for apnoea and need for airway maneuvers (chin lift, jaw thrust and head extension) and the need for oropharyngeal/ nasopharyngeal airway insertions. The acute complications that are looked for are, signs of local anaesthetic systemic toxicity (LAST), accidental vascular puncture during procedure, accidental intravascular injection of anaesthetic solution, pneumothorax (detected by a post-operative ultrasound scan of chest with absent lung sliding, absence of comet tail and Barcode sign in the M mode), phrenic nerve paralysis (ultrasound appearance of paradoxical movement, through diaphragmatic excursion of less than 4 mm, and a difference >50% between the excursion of one hemidiaphragm compared to the other), hoarseness (due to recurrent laryngeal nerve involvement), post-operative nausea and vomiting (PONV) and any other complications (e.g. Horner’s syndrome). Patients are asked about the discomfort or pain felt during the block procedure and the during the surgery via a visual analogue scale (VAS) (0 to 10 with 0= no pain/discomfort and 10=severe pain). Following surgery, patient is taken to the Post anaesthesia care unit (PACU) where according to the modified Aldrete scoring system; a score of >9 permits Phase I discharge from the PACU to ward. The time spent in the PACU is documented by nursing officer blinded to the sedation used. Patients are followed up during their hospital stay by a trained pain management nursing officer blinded to the sedation used, to determine the duration of post-block analgesia time which is defined as the duration from block onset time to when they first registered pain. During the hospital stay, the patient’s post-operative pain will be assessed using a Visual analog scale (VAS- 0- no pain and 10- severe pain) and the type of analgesia used (opioid- Subcutaneous Morphine, non-opioid- paracetamol, diclofenac sodium) and the amounts (mg) used if opioids are used at post-op 1, 6, 12 and 24 hours. They are also observed for adverse side effects of opioid use (nausea, vomiting, constipation). All patients who receive Inter scalnae block (ISB) for anesthesia are followed up for four weeks, weekly, then monthly up to 3 months for potential neurologic complications and to assess the patients’ satisfaction towards the supraclavicular nerve block via a telephone interview by the trained pain management nurse. To detect potential neurological complications, patients are asked a standardized set of questions in relation to the operative limb; do you have any numbness? Do you have any tingling? Do you have any abnormal sensations? Do you have any pain? Do you have any weakness? If the patient complains of any neurological complications, then further queries are to be made taking into account the anatomy relevant to the surgery and the peripheral nerve/plexus block. Symptoms that are immediately adjacent to the wound, consistent with normal tissue healing or the initial trauma are not considered relevant in terms of ISB being a causal factor. For patients with ambiguous symptoms or complaints, repeat contact is made with the patient in another 2 weeks. Triggers for referral to a neurologist are, new onset of motor and/or sensory deficit, non-resolving paraesthesia, pain and allodynia, or dysesthesia. If such neurological referral is done the patient is followed up for their neurological diagnosis/findings.

Blinding Patients are blinded to the sedative used. Investigators are blinded to sedative use as after block placement the anaesthetist looking after the patient collects the data. Anaesthetist who is observing the patient is not blinded as propofol has a distinctive white colour and will collect the intraoperative data . Post anaesthesia care unit nurse is blinded to sedative use. Pain assessment nurse was blinded to group allocation


Inclusion criteria

All consenting patients males and females, with the American Society Anaesthesiologist (ASA) physical status of I or II awaiting arthroscopic shoulder surgery under regional anaesthesia in beach chair position at Teaching Hospital Anuradhapura. Minimum age of patients is 18 years with a maximum of 80 years.


Exclusion criteria

• Patients with significant coagulopathy: Patients with a platelet count of less than 100,000, an international normalizing ratio(INR) more than 1.5 and patients on anticoagulants such as warfarin, heparin and clopidogrel.

• Infection at the injection site • Known allergy to local anaesthetics and sedatives (Propofol & Dexmedomidine) • Inability to cooperate during block placement or surgery • A body mass index more than 35 Kg/m2 • Pre-existing loss of force or sensation in the operative limb • Significant organ dysfunction (cardiac- patients with heart block, bradycardia, severe ventricular dysfunction, hypovolaemia, or chronic uncontrolled hypertension, pulmonary, renal, hepatic impairment and uncontrolled diabetes mellitus) • Failed interscalene block during the present intervention and converted to general anaesthesia.



Primary outcome(s)

1.

Change in systolic blood pressure (SBP) and mean arterial pressure (MAP)

[

At baseline (on arrival at the operating room prior to block placement), then every 15 minutes until the end of propofol or dexmedetomidine infusion

]
2.

Change in heart rate (HR)

[

At baseline (on arrival at the operating room prior to block placement), then every 15 minutes until the end of propofol or dexmedetomidine infusion

]
3.

The need for airway interventions The need for chin lift, jaw thrust & head tilt, airway adjuncts such as nasopharyngeal airway, oropharyngeal airway to maintain the airway

[

When the patient cannot maintain the airway from the start of infusion of Propofol or Dexmedetomidine till the end where infusion is stopped.

]
4.

Length of PACU stay

[

The time duration in minutes measured from the time the patient enters the Post Anaesthesia Care Unit (PACU) to discharge from the PACU following a modified Aldrete score of >9 . The time spent in the PACU is documented by nursing officer blinded to the sedation used

]
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[]
796.
[]
797.
[]
798.
[]
799.
[]
800.
[]
801.
[]
802.
[]
803.
[]
804.
[]
805.
[]
806.
[]
807.
[]
808.
[]
809.
[]
810.
[]
811.
[]
812.
[]
813.
[]
814.
[]
815.
[]
816.
[]
817.
[]
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[]
819.
[]
820.
[]
821.
[]
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[]
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825.
[]
826.
[]
827.
[]
828.
[]
829.
[]
830.
[]
831.
[]
832.
[]
833.
[]
834.
[]
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854.
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856.
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858.
[]
859.
[]
860.
[]
861.
[]

Secondary outcome(s)

1.

Patient Satisfaction 1 (PS1) measures on [I would want to have the same anesthetic again on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree

[

Measured at postoperative 24-hour period.

]
2.

Patient Satisfaction 2 (PS2) [I was satisfied with my anaesthetic care on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree

[

Measured at postoperative 24-hour period.

]
3.

Patient Satisfaction 3(PS3) [I felt relaxed and no pain during the surgery on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree.

[

Measured at postoperative 24-hour period.

]
4.

Postoperative analgesia duration

[

The time duration measured from the time of successful nerve block onset to the first onset of pain postoperatively in minutes

]
5.

Postoperative opioid analgesic consumption

[

Measured from the end of surgery to 24 hours. The total amount in milligrams of prescribed opioids for the patient

]
6.

Complications of interscalene block. Ultrasound evidence of hemi-diaphragmatic paralysis [ultrasound appearance of paradoxical movement, through diaphragmatic excursion of less than 4 mm, and a difference >50% between the excursion of one hemidiaphragm compared to the othe

[

Measured at PACU postoperatively

]
7.

Neurological complications [Patients are asked a standardized set of questions via telephone interview in relation to the operative limb; do you have any numbness? Do you have any tingling? Do you have any abnormal sensations? Do you have any pain? Do you have any weakness? If the patient complains of any neurological complications, then further queries are to be made taking into account the anatomy relevant to the surgery and the peripheral nerve/plexus block. Symptoms that are immediately adjacent to the wound, consistent with normal tissue healing or the initial trauma are not considered relevant in terms of nerve block being a causal factor. ]

[

Measured weekly for the first month then monthly up to 3 months.

]
8.
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531.
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541.
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569.
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[

.

]
611.
[]
612.
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613.
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614.
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615.
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616.
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617.
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619.
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629.
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664.
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669.
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[]
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[]
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[]
709.
[]
710.
[]
711.
[]
712.
[]
713.
[]
714.
[]
715.
[]
716.
[]
717.
[]
718.
[]
719.
[]
720.
[]
721.
[]
722.
[]
723.
[]
724.
[]
725.
[]
726.
[]
727.
[]
728.
[]
729.
[]
730.
[]
731.
[]
732.
[]
733.
[]
734.
[]
735.
[]

Target number/sample size

38 (19 in each group)


Countries of recruitment

Sri Lanka


Anticipated start date

2022-01-01


Anticipated end date

2022-06-30


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Self funded


Regulatory approvals

NA



State of Ethics Review Approval


Status

Approved


Date of Approval

2021-10-01


Approval number

ERC/2020/79


Details of Ethics Review Committee

Name: Ethics Review Committee Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka
Institutional Address:Ethics Review Committee, Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka, Saliyapura, Sri Lanka
Telephone:+94 (0)25 2053633
Email: ethicsreviewcommittee@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Minura Hapugoda
Medical Officer in Anaesthesia
Teaching Hospital Anuradhapura, Anuradhapura, Sri Lanka
0252224810
0718695689

minura1988@gmail.com

Contact Person for Public Queries

Dr. Kariyawasam Athukoralage Don Lewan Priyanjith Kariyawasam
Senior Lecturer and Consultant Anaesthetist
eaching Hospital Anuradhapura, Anuradhapura, Sri Lanka
+94 252224811
+94 773021611

lewan@med.rjt.ac.lk


Primary study sponsor/organization

Dr. Minura Hapugoda
Medical Officer in Anaesthesia
Teaching Hospital Anuradhapura, Anuradhapura, Sri Lanka
0718695689

minura1988@gmail.com

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description

Not applicable


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results