To compare the effect of two different drugs dexmedetomidine and fentanyl on quality of recovery using QoR15 score in patients undergoing laparoscopic cholecystectomy.

Comparison of the effect of intravenous dexmedetomidine versus intravenous fentanyl on quality of recovery in patients undergoing laparoscopic cholecystectomy: A double blind randomized clinical trial. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069387

Enrollment

Registered

2024-06-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: K82- Other diseases of gallbladder Health Condition 2: K80- Cholelithiasis Health Condition 3: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere Health Condition 4: K81- Cholecystitis

Interventions

Intervention1: Dexmedetomidine group: Intravenous Dexmedetomidine 1 microgram per kg over 10 minutes before induction followed by 0.5 microgram per kg continuous infusion till the end of surgery. Cont

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with body mass index between 18.5 to 24.9kg/m2. 2.American society of Anesthesiologists grade I and II. 3.Patients posted for laparoscopic cholecystectomy.

Exclusion criteria

Exclusion criteria: 1.Patient refusal. 2.Known allergy to the drugs to be used. 3.Patients who are alcoholic or drug abuser. 4.Patients with body mass index greater than 30kg/m2. 5.Patients with clinically significant neurologic, psychiatric, cardiovascular, renal and hepatic diseases. 6.Patients who received an opioid analgesic medication within a 24 hour period before surgery. 7.Patients with upper respiratory tract infection, asthma, COPD. 8.Patients with chronic pain.

Design outcomes

Primary

Measure	Time frame
To compare the effect of intravenous dexmedetomidine versus intravenous fentanyl on quality of recovery using QoR 15 questionnaire.Timepoint: At 12 hours, 24 hours,36 hours, 48 hours.	—

Secondary

Measure	Time frame
To compare the postoperative pain using NRS (numeric pain rating scale).Timepoint: Just after surgery. 30 min after surgery. 1 hour after surgery. 2 hour after surgery. 6 hour after surgery.;To compare the total analgesic consumption in postoperative period.Timepoint: Just after surgery. 6hour after surgery. 12hour after surgery. 18hour after surgery. 24hour after surgery.;To compare change in hemodynamic parameters (blood pressure, mean arterial pressure, heart rate, saturation) in perioperative period.Timepoint: Baseline before induction. 5min, 10min, 30 min, 60 min intraoperatively. At extubation. 5 minute after extubation. 10minute after extubation. 30minute after extubation.;Complications of any used drugs if any.Timepoint: nil	—

Measure

Time frame

To compare the postoperative pain using NRS (numeric pain rating scale).Timepoint: Just after surgery. 30 min after surgery. 1 hour after surgery. 2 hour after surgery. 6 hour after surgery.;To compare the total analgesic consumption in postoperative period.Timepoint: Just after surgery. 6hour after surgery. 12hour after surgery. 18hour after surgery. 24hour after surgery.;To compare change in hemodynamic parameters (blood pressure, mean arterial pressure, heart rate, saturation) in perioperative period.Timepoint: Baseline before induction. 5min, 10min, 30 min, 60 min intraoperatively. At extubation. 5 minute after extubation. 10minute after extubation. 30minute after extubation.;Complications of any used drugs if any.Timepoint: nil

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Countries

India

Contacts

Public ContactDr Usha Shukla

Uttar Pradesh University of Medical Sciences, Saifai, Etawah.

ushashukla1970@gmail.com9412201915

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026