A study to know the effects of low dose of Dexmedetomidine (a calming drug) before surgery on the amount of Propofol (a sleep-inducing drug) needed to put patients to sleep during laparoscopic gallbladder removal surgery, while using a monitor to track their level of sleep

The Effect of low-dose Dexmedetomidine premedication on induction dose of Propofol under BIS monitoring in laparoscopic cholecystectomy: a randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/077196

Enrollment

Registered

2024-11-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Interventions

Intervention1: dexmedetomidine IV infusion: Patients in test group will receive IV infusion of Dexmedetomidine 0.5 mcg/kg over 10 minutes as a premedication along with Fentanyl 2mcg/cc in general anae

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I and grade II Laparoscopic cholecystectomy

Exclusion criteria

Exclusion criteria: Preoperative heart rate less than 60 beats per minute Rhythm disturbances Pregnancy Allergic to Propofol or alpha 2 agonist

Design outcomes

Primary

Measure	Time frame
The induction dose of propofol after low dose dexmedetomidine premedicationTimepoint: At induction- 3 minutes after stopping dexmedetomidine infusion(at loss of verbal response)	—

Secondary

Measure	Time frame
The changes in BIS value at induction Timepoint: 5 min,10 min, at loss of consciousness,at intubation, post intubation at 3 min, 6 min, 9 min,12 min, 15 min ;The hemodynamic response to intubation Timepoint: At intubation, post intubation at 3 min, 6 min, 9 min,12 min, 15 min;Total intraoperative requirement of analgesics(Fentanyl)Timepoint: during intraoperative period;Post operative pain scores(NRS)Timepoint: Post operative period at 1, 2, 4, 6, 24 hours;Side effects, if anyTimepoint: Intraoperatively and post operatively	—

Measure

Time frame

The changes in BIS value at induction Timepoint: 5 min,10 min, at loss of consciousness,at intubation, post intubation at 3 min, 6 min, 9 min,12 min, 15 min ;The hemodynamic response to intubation Timepoint: At intubation, post intubation at 3 min, 6 min, 9 min,12 min, 15 min;Total intraoperative requirement of analgesics(Fentanyl)Timepoint: during intraoperative period;Post operative pain scores(NRS)Timepoint: Post operative period at 1, 2, 4, 6, 24 hours;Side effects, if anyTimepoint: Intraoperatively and post operatively

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Countries

India

Contacts

Public ContactDr Sharon Chacko

Employees State Insurance - Post Graduate Institute of Medical Sciences and Research, Basaidarapur

nagpalvijaykumar@gmail.com9968304240

Outcome results

None listed

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