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Comparative evaluation of intraoperative anti- nociception efficacy with opioid(fentanyl) versus opioid free anesthesia(ketamine and lidocaine and magnesium sulphate) in patients undergoing laparoscopic cholecystectomy

comparative evaluation of intraoperative anti- nociception efficacy with opioid(fentanyl) versus opioid free anesthesia(ketamine and lidocaine and magnesium sulphate) in patients undergoing laparoscopic cholecystectomy - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092288
Enrollment
54
Registered
2025-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: fentanyl: patients will receive an intravenous bolus injection of fentanyl 2 microgram per kg f/b infusion at 1 microgram per kg per hour. repeat dose of fentanyl 10 microgram intraveno

Sponsors

School of Medical Sciences and Research Sharda university
Lead Sponsor

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 lidocaine and Magnesium Sulphate. History of chronic usage of opioids and any other analgesics. Pregnant females History of psychiatric illness. History of endocrine disease example diabetes mellitus and thyroid disease. History of CNS or Cardiovascular and renal disease.

Design outcomes

Primary

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

Secondary

MeasureTime frame
1) To evaluate & compare the intraoperative anti-nociception efficacy with opioid (fentanyl) versus opioid free anaesthesia (Ketamine, lidocaine & Magnesium sulphate) 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)Timepoint: peri operative monitoring till 24 hours post operatively;To evaluate & compare opioid (fentanyl) versus opioid free anaesthesia (Ketamine, lidocaine & Magnesium sulphate) 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 & magnesium sulphate.Timepoint: peri operative till post operative 24 hours.

Countries

India

Contacts

Public ContactDr UC 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