Study on comparing drug response of dexmedetomidine and ketamine with fentanyl and morphine (drug name) for laparoscopic operation

Phase 1

Not yet recruiting

• Conditions: Calculus of gallbladder with acutecholecystitis,

• Registration Number: CTRI/2023/07/055452
• Lead Sponsor: P Ramyadevi

Brief Summary

The Study is to Compare theEfficacy of Opioid-Free and Opioid-Based Anaesthesia in terms ofIntraoperative Hemodynamic Stability and Post operative Analgesia in patientsundergoing Elective Laparoscopic Surgery under General Anaesthesia.

Thehypothesis in this study is an opioid-free anaesthetic regimenconsisting of both dexmedetomidine and ketamine infusions, along with intravenous(IV) paracetamol, and magnesium as a co-analgesic, is an effectivealternative anaesthetic technique, compared to the opioid-based anaesthetic regimenregarding intraoperative hemodynamic stability, postoperative pain intensity,and the incidence of side effects in the early post operative period.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-20
• Study Start: 2023-07-28

Recruitment & Eligibility

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

Inclusion Criteria

BMI: 18.5 – 24.9 ASA (American Society of Anaesthesiologists) physical status of I and II.

Exclusion Criteria

Pregnant and Lactating Women ASA physical status of III and IV Significant pain related neurological conditions Patients currently taking opioid Patients with allergies to study medication Patient Refusal H/O Drug Abuse, Psychiatric disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean systolic blood pressure between opioid free & opioid based anesthesia study groups for elective laparoscopic surgery.	It will be monitored at baseline, before induction, post induction 3min, before intubation, post intubation 1 min, beginning of surgery, bef | ore abdominal insufflation, post abdominal insufflation 3min, 15 min,30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min & 150 min from induction , post deflation 3min, before extubation, after extubation 1min.

Secondary Outcome Measures

Name	Time	Method
To compare the use of Postoperative Rescue Analgesia & the use of rescue for Postoperative Nausea & Vomiting.	Postoperative pain will be assessed by visual analog scale score at 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours.

Trial Locations

Locations (1)

Sri Venkateshwaraa Medical College Hospital and Research Centre; 🇮🇳 Pondicherry, PONDICHERRY, India

Sri Venkateshwaraa Medical College Hospital and Research Centre

🇮🇳Pondicherry, PONDICHERRY, India

Dr P Ramyadevi

Principal investigator

9698582635

ramya10076@gmail.com