To compare a drug (paracetamol) with another (dexamethasone) given either in vein or inhaled as vapour in preventing sore throat after operation

Recruiting

Conditions: Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,

Registration Number: CTRI/2019/02/017541

Lead Sponsor: Safdarjung Hospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 150

Inclusion Criteria

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.
Either gender, aged 18-65 years.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Safdarjung Hospital
🇮🇳
South, DELHI, India
Safdarjung Hospital
🇮🇳South, DELHI, India
Smita Prakash
Principal investigator
911126163072
drsunilprakash@gmail.com