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Clinical trial to study the effect of two types of drugs Fentanyl and Dexmedetomidine plus ketamine for postoperative pain for patients undergoing laparoscopic cholecystectomy

A randomized comparative study to evaluate postoperative analgesia between opioid based and opioid free anesthesia in patients undergoing laparoscopic cholecystectomy - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098389
Enrollment
104
Registered
2025-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K80- Cholelithiasis

Interventions

Intervention1: opioid based anaesthesia group (OBA) : In opioid based anaesthesia group (OBA) Fentanyl 2 g/kg will be given and 0.5 g/Kg Bolus will be given to maintain patient BP within 20% of p

Sponsors

M S Ramaiah Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients aged 18 to 60 years 2) American Society of Anaesthesiologists (ASA) classification II or III physical status with BMI of less than 30 kg/m2 3) Patients undergoing Laparoscopic Cholecystectomy

Exclusion criteria

Exclusion criteria: 1. Patients with severe cardiovascular, renal, hepatic disorder 2. Patients with neuropsychiatric disorders 3. Patients with hemodynamic instability 4. Patients with drug allergy 5. Patients with history of malignant hyperthermia and Muscular dystrophy 6. Patients with muscular dystrophy 7. Patients with electrolyte imbalance 8. Patients with History of opioid use 1 month prior to surgery, 9. Patients with chronic opioid addiction 10. Patients with inability to comprehend visual analog scale (VAS)

Design outcomes

Primary

MeasureTime frame
To compare time to first rescue analgesia between Opiod free Anaesthesia and Opiod based Anaesthesia groups.Timepoint: Patients will be monitored for postoperative pain and any analgesic requirement 30 minutes after recovery, hourly for 2 hours and every 4 hourly for a period of 24 h.—

Secondary

MeasureTime frame
1. To Compare Total Rescue analgesic consumption in first 24hrs. 2. Postoperative pain scores will be assessed using the Visual Analogue Scale (VAS) at specific time intervals 1 hour, 6 hours, 12 hours, & 24 hours post-surgery. 3. Incidence of Post operative Nausea & Vomiting (PONV) Timepoint: 24 hours after surgery ;Postoperative pain scores will be assessed using the Visual Analogue Scale (VAS) at specific time intervals 1 hour, 6 hours, 12 hours, & 24 hours post-surgery.Timepoint: VAS score will be assessed at 1,6,12 & 24 hours after surgery.;Incidence of post operative nausea vomitingTimepoint: 1 hour after surgery—

Countries

India

Contacts

Public ContactDr Archana S

M S Ramaiah Medical College

archvinddoc@yahoo.co.in9845121444

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026