A study to understand the advantages of intrathecal clonidine compared to combination of clonidine with fentanyl in patients undergoing laparoscopic surgeries

Not yet recruiting

• Conditions: Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K36||Other appendicitis,

• Registration Number: CTRI/2019/08/020928
• Lead Sponsor: Bangalore Medical College and Research Institute

Brief Summary

This is a prospective randomized double blind study comparing the efficacy of intrathecal clonidine 150 micrograms versus intrathecal clonidine 75 micrograms with intrathecal fentanyl 25 micrograms in patients undergoing elective laparoscopic surgeries of duration less than 2 hours under conventional general anaesthesia. iI will be conducted in a total of 60 patients, 30 in each group, in alll the hospitals attached to Bangalore Medical College and Research Institute.The primary outcome is to compare the intraoperative haemodynamic variables along with the haemodynamic response to intubation and extubation. Duration of post operative analgesia and sedation status will also be observed in the post operative period.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-09
• Last Update Posted: 2019-08-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1. Patients willing to give informed written consent.
• 2. ASA physical status I and II patients.
• 3. Patients of age group 18-55 years, of either sex.
• 4. Patients undergoing elective laparoscopic surgeries under general anaesthesia lasting less than 2 hours.
• 5. Patients with Body Mass Index between 18 to 30 kilograms per metre square.

Exclusion Criteria

• 1. Patients with contraindications to spinal technique.
• 2. Patients with known allergy to clonidine and fentanyl.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Haemodynamic variables	Intraoperative period - every five minutes till 30 minutes followed by every ten minutes till 60 minutes followed by every fifteen minutes till the end of the surgery

Secondary Outcome Measures

Name	Time	Method
Haemodynamic response to intubation and extubation	After one minute and five minutes of intubation and after one minute and five minutes of extubation
Analgesia	The time required for the patient in the post operative ward for the first rescue analgesic when Visual analogue score is greater than 3
Sedation	Five minutes immediately after extubation in the post operative period
Incidence of hypotension, hypertension, bradycardia, tachycardia	24 hours in the post operative period

Trial Locations

Locations (1)

OT Complex, Victoria Hospital; 🇮🇳 Bangalore, KARNATAKA, India

OT Complex, Victoria Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Nazneen Makhbool

Principal investigator

9113654177

singwdluv@gmail.com