| CTRI Number |
CTRI/2019/02/017541 [Registered on: 07/02/2019] Trial Registered Prospectively |
| Last Modified On: |
03/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare a drug (paracetamol) with another (dexamethasone) given either in vein or inhaled as vapour in preventing sore throat after operation |
|
Scientific Title of Study
|
Comparative evaluation of preoperative paracetamol and a combination of paracetamol with nebulised or intravenous dexamethasone for prevention of postoperative sore throat |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Singh Rathore |
| Designation |
Post Graduate Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Main Operation Theatre, 2nd Floor, Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 New Delhi 11002
South
DELHI
110029
India |
| Phone |
26198462 |
| Fax |
911126163072 |
| Email |
sandeeprathore411@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smita Prakash |
| Designation |
Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Main Operation Theatre, 2nd Floor, Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 New Delhi 110029
South
DELHI
110029
India |
| Phone |
26198462 |
| Fax |
911126163072 |
| Email |
drsunilprakash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smita Prakash |
| Designation |
Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Main Operation Theatre, 2nd Floor, Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 New Delhi 110029
South
DELHI
110029
India |
| Phone |
26198462 |
| Fax |
911126163072 |
| Email |
drsunilprakash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi 110029
|
|
|
Primary Sponsor
|
| Name |
Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Smita Prakash |
Safdarjung Hospital |
Main Operation Theatre, 2nd Floor, Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi 110029 New Delhi 110029
South
DELHI |
26198462
911126163072
drsunilprakash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Safdarjang Hospital and VMMC, New Delhi 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone Paracetamol |
Dexamethasone 8mg will be given nebulised or intravenous with paracetamol 1g intravenous before anaesthesia induction for 15 min |
| Comparator Agent |
Paracetamol |
Paracetamol 1g will be given intravenously before anaesthesia induction for 15 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling the criteria of American Society of Anesthesiologists Physical Status I and II adults
2. scheduled for elective laparoscopic cholecystectomy under general anaesthesia with tracheal intubation.
3. Either gender, aged 18-65 years
|
|
| ExclusionCriteria |
| Details |
1. Patients with a history of recent respiratory tract infection or sore throat within <2 weeks
2. Patients with anticipated difficult intubation
3. Patients receiving analgesic or steroid therapy or known allergy to study drugs
4. Patients with diabetes, obesity, cardiac, respiratory, hepatic or renal disease
5. Pregnant women
6. Surgery duration greater than 3 hours
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of postoperative sore throat in patients receiving preoperative intravenous paracetamol and a combination of paracetamol with nebulised or intravenous dexamethasone |
At recovery 0,1, 6, 12 and 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the severity of postoperative sore throat among the three groups.
2. To compare the incidence of hoarseness of voice and cough among the groups.
|
At recovery 0,1, 6, 12 and 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Postoperative sore throat (POST) is a common complication following general anaesthesia which is distressing to the patient. Dexamethasone is a corticosteroid with potent analgesic, anti-inflammatory and antiemetic action. Paracetamol is an effective analgesic and antipyretic agent commonly used for intraoperative and postoperative analgesia. The present study plans to evaluate the effect of preoperative administration of paracetamol and a combination of paracetamol with nebulised or intravenous dexamethasone for prevention of postoperative sore throat. The study hypothesis is that a combination of intravenous paracetamol with nebulised or intravenous dexamethasone is superior to intravenous preoperative paracetamol alone in decreasing the incidence of postoperative sore throat in adult patients undergoing elective laparoscopic cholecystectomy under general anaesthesia with tracheal intubation. The aim of this study is to evaluate the effect of preoperative administration of paracetamol and a combination of paracetamol with nebulised or intravenous dexamethasone for prevention of postoperative sore throat, hoarseness of voice and cough in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia with tracheal intubation. Patients will be randomised into one of the three study groups ( 50 patients in each group)with the help of computer generated random number table in blocks of ten. Group P: Patients will receive nebulised normal saline (5 ml) + IV normal saline (5ml) + IV paracetamol 1g infusion. Group I: Patients will receive nebulised normal saline (5 ml) + IV dexamethasone 8mg (5ml) + IV paracetamol 1g infusion. Group N: Patients will receive nebulised dexamethasone 8mg (5ml) + IV Normal saline (5ml) + IV Paracetamol 1g infusion.
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