CTRI/2020/01/022685RecruitingNot Applicable
A comparative study between oral clonidine and oral pregabalin on perioperative haemodynamic response and post operative analgesia in patients undergoing laparoscopic cholecystectomy under general anaesthesia
JLN Medical college and hospital Ajmer1 site in 1 country60 target enrollmentStarted: November 1, 2020Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Haemodynamic changes
Study Overview
Brief Summary
Theaim of this study is to compare and evaluate the efficacy of two different drugoral clonidine and oral pregabalin in perioperative haemodynamic response tolaryngoscopy, endotracheal intubation, pneumoperitonium and post operativeanalgesia and sedation with respect to-
PRIMARY OBJECTIVE-
- Haemodynamic changes
SECONDARY OBJECTIVES-
1. Postoperative analgesia
2. Levelof Sedation
- Any significant side effects or complications
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patients of ASA grade I and II aged between 18 and 60 years of either sex posted for laparoscopic cholecystectomy surgery under general anaesthesia.
Exclusion Criteria
- •ASA grade III and above.
- •Age <18 years & > 60 years.
- •Patients with severe systemic disease like IDDM, uncontrolled hypertension, kidney and liver disease, severe respiratory disease.
- •Seizure disorder.
- •Coronary artery disease or recent history of MI.
- •Anticipated difficult intubation.
- •Body weight>100 kg or obese.
- •Pregnant and lactating women.
- •Mentally impaired patients.
- •Patients of psychiatric disorders and sleep disorders.
- •Patients on steroids since last 6 months.
- •Hypersensitivity to study drugs.
Outcomes
Primary Outcomes
Haemodynamic changes
Time Frame: 1 year
Secondary Outcomes
- Post operative analgesia(Level of Sedation)
Investigators
Study Sites (1)
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