A Study Comparing Different Anaesthesia Approaches for Pain Relief During Gallbladder Surgery

Comparative Evaluation of Intraoperative Anti-Nociception Efficacy With Opioid Anaesthesia (Fentanyl) vs Opioid-Free Anaesthesia (Dexmedetomidine, Ketamine, Lignocaine) in Patients Undergoing Laparoscopic Cholecystectomy - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/095028

Enrollment

Registered

2025-09-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: - Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: FENTANYL: Patients will receive an intravenous bolus injection of fentanyl 2 microgram per kg followed by infusion at 1 microgram per kg per hour will be started after 10 minutes. Repea

Eligibility

Inclusion criteria

Inclusion criteria: Patient scheduled for laparoscopic cholecystectomy Age between 18 to 60 years ASA grade I and II Both genders Duration of surgery less than and equal to two hours

Exclusion criteria

Exclusion criteria: BMI more than 30 kg per meter square Patient having history of drug allergy to Ketamine and Lignocaine or Dexmedetomidine History of usage of opioids and any other analgesics Pregnant females History of psychiatric illness History of endocrine disease-diabetes mellitus and thyroid disease, History of CNS, Cardiovascular or renal disease

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the intraoperative anti nociception efficacy with opioid versus opioid free anaesthesia (Ketamine, lidocaine and Dexmedetomidine) by change in SPI in response to surgical noxious stimulation following skin incision till 24 hours.Timepoint: Perioperative till 24 hours.	—

Secondary

Measure	Time frame
1) To evaluate & compare the intraoperative anti nociception efficacy with opioid (fentanyl) versus opioid free anaesthesia (Ketamine, lidocaine & Dexmedetomidine) with regard to:- a) SPI (before & after intubation, before skin incision, before & after skin closure, before & after extubation) b) HR, MAP, Lacrimation, sweating (before & after intubation, skin incision, skin closure & extubation) 2) To evaluate & compare opioid (fentanyl) versus opioid free anaesthesia (Ketamine, lidocaine & Dexmedetomidine) with regard to:- a) Duration of Postoperative analgesia & pain severity b) Incidence of Postoperative Nausea & Vomiting c) Duration of discharge from Post Anaesthetic Care Unit d) Post operative assessment of awarness e) Total consumption of propofol, fentanyl, cis-atracurium, ketamine, lidocaine & dexmedetomidineTimepoint: Perioperative till 24 hours (postoperatively)	—

Measure

Time frame

1) To evaluate & compare the intraoperative anti nociception efficacy with opioid (fentanyl) versus opioid free anaesthesia (Ketamine, lidocaine & Dexmedetomidine) with regard to:- a) SPI (before & after intubation, before skin incision, before & after skin closure, before & after extubation) b) HR, MAP, Lacrimation, sweating (before & after intubation, skin incision, skin closure & extubation) 2) To evaluate & compare opioid (fentanyl) versus opioid free anaesthesia (Ketamine, lidocaine & Dexmedetomidine) with regard to:- a) Duration of Postoperative analgesia & pain severity b) Incidence of Postoperative Nausea & Vomiting c) Duration of discharge from Post Anaesthetic Care Unit d) Post operative assessment of awarness e) Total consumption of propofol, fentanyl, cis-atracurium, ketamine, lidocaine & dexmedetomidineTimepoint: Perioperative till 24 hours (postoperatively)

—

Countries

India

Contacts

Public ContactDr U C Verma

School of Medical Sciences and Research, Sharda University

uttam.verma@sharda.ac.in9968604211

Outcome results

None listed

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