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Effectiveness of nebulised Ketamine on the incidence and severity of post-operative sore throat in patients undergoing general anesthesia with tracheal intubation: a Randomized Controlled Clinical Trial -

SLCTR Registration Number

SLCTR/2017/015


Date of Registration

09 Jun 2017

The date of last modification

Jun 09, 2017



Application Summary


Scientific Title of Trial

Effectiveness of nebulised Ketamine on the incidence and severity of post-operative sore throat in patients undergoing general anesthesia with tracheal intubation: a Randomized Controlled Clinical Trial


Public Title of Trial

Effectiveness of Ketamine nebulisation in reducing sore throat following surgery under General Anesthesia


Disease of Health Condition(s) Studied

Post-operative sore throat


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1197-4549


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

AEC/REV/2016/01 (Azeezia Ethics Committee)


Trial Details


What is the research question being addressed?

What is the effectiveness of ketamine nebulisation administered before induction of anesthesia, in attenuating post-operative sore throat (POST) in patients undergoing general anesthesia(GA) with tracheal intubation?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Prevention


Intervention(s) planned

The study will be conducted at the Department of Anesthesiology, Azeezia Medical College Hospital, Kerala, India.

Consenting participants meeting the inclusion/exclusion criteria will be randomized into two arms of the trial, using a computer generated random numbers and sequential allocation using sealed opaque envelopes.

Arm 1: patients receiving a single administration of ketamine 50 mg (1ml) with saline (4ml) nebulization
Arm 2: patients receiving a single administration of saline nebulisation (5 ml)

Nebulisation will be administered for 15 minutes and anesthesia will be induced 15 minutes later. Both the investigator assessing the outcome as well as patients will be blinded to the intervention,since the ketamine preparation administered will be tasteless, colourless and odourless. After opening the envelope anesthesia assistant who have no contact with the study participants and no role in assessing outcomes will be administering nebulisation.

Anesthesia protocol will be standardized for all patients.


Inclusion criteria

  1. Male and female patients of American Society of Anaesthesiologists (ASA) physical status 1-2
  2. Aged between 18-60 years
  3. Undergoing general anesthesia with tracheal intubation, of duration up to 2 hours.

Exclusion criteria

  1. A history of pre-operative sore throat
  2. Oral and nasal surgeries
  3. Upper respiratory tract infection
  4. Chronic obstructive pulmonary disease
  5. Head and neck surgeries
  6. Pregnant females
  7. Mallampati grade >2
  8. Known allergies to study drug
  9. Those who required more than one attempt at intubation


Primary outcome(s)

1) Effectiveness of nebulised ketamine in reducing post-operative sore throat in adult patients undergoing GA of duration of up to 2 hour.

2) Incidence and severity of post-operative sore-throat in patients after GA Tools used to measure will be a 4 point scale: 0 - No sore throat even on asking 1 - Mild sore throat (complaints of sore throat only on asking) 2 - Moderate sore throat (complains of sore throat his/her own) 3 - Severe sore throat (complaints of throat pain,hoarseness of voice and in obvious distress)


Primary outcome(s) - Time of assessment(s)

Assessment will be done at 0,2,4,6,12 and 24 h after extubation.


Secondary outcome

Side-effects

  1. Nausea and vomiting
  2. Cough
  3. Dry mouth
  4. Hallucination
  5. Respiratory depression
  6. Hemodynamic instability.

Tools used to measure will be:

Post-op nausea and vomiting will be graded on a four-point ordinal scale (0 = no nausea, 1 = mild nausea, 2 = moderate nausea, 3 = severe nausea with vomiting)

Cough: 0 – No cough at any time since operation 1 – Minimal cough 2 – Moderate cough 3 - Severe cough

Dry mouth: 1. No disability 2. Dryness requiring additional fluids for swallowing 3. Dryness causing dietary alterations,interference with sleep,speaking

Hallucination: Very mild: While resting or going to sleep, sees visions, smells odours, or hears voices Mild: While in a clear state of consciousness, hears a voice calling the subject’s name, experiences non-verbal auditory hallucinations (e.g., sounds or whispers), formless visual hallucinations Moderate: Occasional verbal, visual, gustatory, olfactory, or tactile hallucinations with no functional impairment Moderately Severe: Experiences daily hallucinations OR some areas of functioning are disrupted by hallucinations. Severe: Experiences verbal or visual hallucinations several times a day Extremely Severe: Persistent verbal or visual hallucinations throughout the day

Respiratory depression: Key clinical signs include 1. Respiratory rate less than 8 breaths/minute 2. SpO2 less than 90% in the absence of abnormal baseline SpO2 3.Cardio pulmonary arrest.

Hemodynamic instability: Key signs and symptoms include 1. Hypotension (A blood pressure < 90/60 mm Hg or mean arterial pressure <65 mm Hg ) 2. Hypertension(a blood pressure >140/90 mmHg or a MAP >105 mm Hg ) 2. Abnormal heart rate 3. Decreased urine output 4. Altered consciousness


Secondary outcome(s) - Time of assessment(s)

Side-effects

  1. Nausea and vomiting
  2. Cough
  3. Dry mouth
  4. Hallucination
  5. Respiratory depression
  6. Hemodynamic instability.

Tools used to measure will be:

Post-op nausea and vomiting will be graded on a four-point ordinal scale (0 = no nausea, 1 = mild nausea, 2 = moderate nausea, 3 = severe nausea with vomiting)

Cough: 0 – No cough at any time since operation 1 – Minimal cough 2 – Moderate cough 3 - Severe cough

Dry mouth: 1. No disability 2. Dryness requiring additional fluids for swallowing 3. Dryness causing dietary alterations,interference with sleep,speaking

Hallucination: Very mild: While resting or going to sleep, sees visions, smells odours, or hears voices Mild: While in a clear state of consciousness, hears a voice calling the subject’s name, experiences non-verbal auditory hallucinations (e.g., sounds or whispers), formless visual hallucinations Moderate: Occasional verbal, visual, gustatory, olfactory, or tactile hallucinations with no functional impairment Moderately Severe: Experiences daily hallucinations OR some areas of functioning are disrupted by hallucinations. Severe: Experiences verbal or visual hallucinations several times a day Extremely Severe: Persistent verbal or visual hallucinations throughout the day

Respiratory depression: Key clinical signs include 1. Respiratory rate less than 8 breaths/minute 2. SpO2 less than 90% in the absence of abnormal baseline SpO2 3.Cardio pulmonary arrest.

Hemodynamic instability: Key signs and symptoms include 1. Hypotension (A blood pressure < 90/60 mm Hg or mean arterial pressure <65 mm Hg ) 2. Hypertension(a blood pressure >140/90 mmHg or a MAP >105 mm Hg ) 2. Abnormal heart rate 3. Decreased urine output 4. Altered consciousness



Target number/sample size

96 (48 in each arm)


Countries of recruitment

India


Anticipated start date

2017-06-15


Anticipated end date

2017-11-30


Recruitment status

Pending


State of ethics review approval

Approved by the Institutional Ethics Review Board, Azeezia Medical College Hospital, Kerala, India on 27.04.2016 (Ref: AEC/REV/2016/01)


Funding source

None (investigator funded)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Derlin Thomas
Assistant Professor
Department of Anesthesiology, Azeezia Medical College Hospital, Meeyannoor, Kollam, Kerala, India.
09447768944
09447768944

derlin.t@gmail.com

Contact Person for Public Queries

Dr. Derlin Thomas
Assistant Professor
Department of Anesthesiology, Azeezia Medical College Hospital, Meeyannoor, Kollam, Kerala, India.
09447768944
09447768944

derlin.t@gmail.com


Primary study sponsor/organization

Department of Anesthesiology Azeezia Medical College Hospital

Kollam, Kerala, India
Tel: 0474-2722222
Fax: 0474-2722397

http://www.azeezia.com

Secondary study sponsor (If any)

None