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A Study Comparing Two Medicines (Fentanyl and Dexmedetomidine) to Reduce Stress During Keyhole Gallbladder Surgery

Fentanyl versus Dexmedetomidine infusion for attenuation of the stress response to pneumoperitoneum during laparoscopic cholecystectomy: A randomized clinical trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090006
Enrollment
60
Registered
2025-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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 Health Condition 2: K81- Cholecystitis Health Condition 3: K82- Other diseases of gallbladder Health Condition 4: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere

Interventions

Intervention1: Dexmedetomidine Infusion: Dexmedetomidine 20microgram diluted in 20ml normal saline will be infused at 10ml/hr to ensure a dose of 0.2micro gram per kg per hr. Intervention2: Fentanyl I

Sponsors

Dojingla Yimchunger
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex. 2. Age groups: 18-60 years. 3. ASA (American Society of Anesthesiology)15 Grade I and II. 4. Undergoing Laparoscopic Cholecystectomy.

Exclusion criteria

Exclusion criteria: Patients with uncontrolled hypertension despite of treatment. Patient with Diabetes Mellitus (with autonomic neuropathy) despite of treatment. Anticipated Difficult airway. Conversion to open cholecystectomy. Hypersensitive to study drugs. Refusal to give consent. Severely deranged renal and hepatic function.

Design outcomes

Primary

MeasureTime frame
To compare the attenuation of hemodynamic stress response to pneumoperitoneum among study groups.Timepoint: Hemodynamic parameters namely heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) will be recorded at multiple defined time points. These include the baseline values recorded before induction of anesthesia, just before the creation of pneumoperitoneum (when the study drug infusion is started), and at 1, 3, and 5 minutes after pneumoperitoneum. Subsequently, these parameters will be monitored at every 10-minute interval throughout the duration of pneumoperitoneum and finally at the time of deflation of the pneumoperitoneum, which also coincides with the stopping of the study drug infusion.groups.

Secondary

MeasureTime frame
To compare 1. The sedative effects and duration of analgesia. 2. The time of first rescue analgesia request. 3. Side effects such as hypotension and bradycardia. Timepoint: Sedative effects will be assessed using the Ramsay Sedation Score at 15 and 30 minutes after extubation in the post-anesthesia care unit (PACU). The duration of analgesia will be measured from the point of stopping the study drug infusion to the time of the first request for rescue analgesia, which is determined when the patient reports a Visual Analogue Scale (VAS) pain score of 4 or more. The exact time of this first request will be documented. In addition, side effects such as hypotension, bradycardia, and postoperative nausea and vomiting (PONV) will be monitored throughout the intraoperative period and during the first two hours of observation in the PACU.

Countries

India

Contacts

Public ContactDr L Pradipkumar Singh

Regional Institute of Medical Sciences, Imphal

drlaithangba@gmail.com7005238251

Outcome results

None listed

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