Comparison of intraoperative antinociception efficacy with opioid vs opioid free anaesthesia.

Comparative evaluation of Intraoperative antinociception efficacy with opioid (Fentanyl) vs opioid free anaesthesia (ketorolac, dexmedetomidine and ketamine) in patients undergoing Laparsocopic Cholecystectomy - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091974

Enrollment

Registered

2025-07-30

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: K800- Calculus of gallbladder with acutecholecystitis Health Condition 2: K800- Calculus of gallbladder with acutecholecystitis Health Condition 3: K800- Calculus of gallbladder with acutecholecystitis

Interventions

Intervention1: Comparative evaluation of antinociception efficacy of opioid vs opioid free anaesthesia: Comparison of opioid (fentanyl) vs opioid free anaesthesia (ketamine, dexmedetomidine, ketorolac

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient scheduled for Laparoscopic cholecystectomy 2.Age 18-60 years 3.ASA grade 1 and 2 4.Both genders 5.Duration of surgery less than 2 hours

Exclusion criteria

Exclusion criteria: BMI more than 30 kg per meter square History of CNS, vascular, renal and respiratory diseases History of endocrine disease-diabetes mellitus and thyroid disease History of psychiatric illness Pregnant females History of usage of opioids and any other analgesics Patient having history of drug allergy to ketamine, ketorolac and dexmedetomidine

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the intraoperative anti nociception efficacy with opioid vs opioid free anaethesia (ketamine, dexmedetomidine, ketorolac) by change in SPI in response to surgical noxious stimulation following skin incisionTimepoint: 24 hrs	—

Secondary

Measure	Time frame
1. To evaluate and compare the intraoperative anti-nociception efficacy with opioid (fentanyl) vs opioid free anaesthesia (Ketamine, Dexmedetomidine and Ketorolac) with regard to: - a) SPI b) HR, MAP, Lacrimation, sweating Timepoint: 24 hrs;2) To evaluate and compare the intraoperative anti-nociception efficacy with opioid (fentanyl) vs opioid free anaesthesia (Ketamine, Dexmedetomidine and Ketorolac) with regard to: - a) Duration of Postoperative analgesia and pain severity b)Duration of Postoperative Nausea and Vomiting c)Duration of discharge from Post Anaesthetic Care Unit d)Post operative assessment of awareness e)Total consumption of propofol, fentanyl, cis-atracurium, ketamine, Dexmedetomidine and Ketorolac. Timepoint: 24 hrs	—

Measure

Time frame

1. To evaluate and compare the intraoperative anti-nociception efficacy with opioid (fentanyl) vs opioid free anaesthesia (Ketamine, Dexmedetomidine and Ketorolac) with regard to: - a) SPI b) HR, MAP, Lacrimation, sweating Timepoint: 24 hrs;2) To evaluate and compare the intraoperative anti-nociception efficacy with opioid (fentanyl) vs opioid free anaesthesia (Ketamine, Dexmedetomidine and Ketorolac) with regard to: - a) Duration of Postoperative analgesia and pain severity b)Duration of Postoperative Nausea and Vomiting c)Duration of discharge from Post Anaesthetic Care Unit d)Post operative assessment of awareness e)Total consumption of propofol, fentanyl, cis-atracurium, ketamine, Dexmedetomidine and Ketorolac. Timepoint: 24 hrs

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Countries

India

Contacts

Public ContactDr Uttam Chandra 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