Comparing two drugs for prevention of sore throat after laparoscopic surgery

Not yet recruiting

• Conditions: Malignant neoplasm of bladder, unspecified,

• Registration Number: CTRI/2020/01/022922
• Lead Sponsor: Dr Divya Abhishek Kishore

Brief Summary

This is a prospective , double blind, single centric, three arm, randomized controlled trial comparing two groups of anaesthetic drugs with eachother and with placebo for prevention of post operative sore throat in 135 adult patients of either sex undergoing elective laparoscopic surgery in Trendelenburg position. The patients shall be randomly allocated to either of the three groups D (1microgram/kg dexmedetomedine),group LS(ligocaine 1.5mg/kg+8mg dexamethasone),group N(normal saline). These drugs are expected to reduce the incidence and severity of post operative sore throat both at rest and during swallowing. The primary outcome measure is postoperative sore throat at 15mins, 1h, 6h,12h and 24h postoperatively. The secondary outcome measures are postoperative sore throat on swallowing at 15min, 1h, 6h, 12h and 24 h post operatively, total morphine consumption measured at 24h postoperatively, percentage of glottic opening score measured at 2sec before intubation and blood staining of  the endotracheal tube noted 30sec post extubation.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-01-23
• Study Start: 2020-01-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

ASA physical status I-III, Undergoing elective laparoscopic surgery in Trendelenburg position Requiring endotracheal intubation Duration of surgery>90minutes Expected to remain admitted in the hospital for >24hours.

Exclusion Criteria

Patients with preexisting sore throat/ hoarsen · ASA physical status IV · BMI > 30 · Vocal performer by occupation · Recent or recurrent respiratory tract infection ·Risk of postoperative aspiration (obesity, pregnancy ) · Pain medications, corticosteroids ; calcium channel blocker · 2nd and 3rd degree Heart block · Allergy to Study drugs ·Anticipated difficult intubation(Mallampati grade >2, difficult mask ventilation requiring oral/nasal airway, Cormack and Lehane grade III-IV) Intubation attempt >1.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post operative sore throat	15min,1h,6h,12h,24h

Secondary Outcome Measures

Name	Time	Method
Post operative sore throat on swallowing	15min,1h,6h,12h,24h
Percentage of glottic opening score	2 seconds before endotracheal intubation
Bloodstain over endotracheal tube	30 sec post extubation
Total morphine consumption	24h after surgery

Trial Locations

Locations (1)

Rajiv Gandhi Cancer Institute and Research Centre; 🇮🇳 West, DELHI, India

Rajiv Gandhi Cancer Institute and Research Centre

🇮🇳West, DELHI, India

Dr Abhishek Kishore

Principal investigator

9891777777

drabhi78@gmail.com