To compare the effect of drug Dexmedetomidine with a placebo on the blood pressure and heart rate in patients undergoing Laparoscopic gall bladder removal surgery

EFFECT OF DEXMEDETOMIDINE INFUSION ON PERIOPERATIVE HAEMODYNAMIC STABILITY IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY: A PLACEBO CONTROLLED, RANDOMISED BLINDED STUDY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/026037

Enrollment

Registered

2020-06-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: R098- Other specified symptoms and signsinvolving the circulatory and respiratory systems

Interventions

Intervention1: Dexmedetomidine hydrochloride: Intravenous infusion of Dexmedetomidine hydrochloride at the rate of 0.4 microgram per kilogram of body weight per hour in Sodium Chloride 0.9% via syring

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients with valid consent 2) American Society of Anaesthesiologists Physical Status 1 or 2 3) Undergoing elective laparoscopic cholecystectomy requiring endotracheal intubation

Exclusion criteria

Exclusion criteria: 1) Patient refusal 2) Patients having known allergy either to Dexmedetomidine or any of the drugs to be administered 3) Patients with airway problems (anticipated/ unanticipated difficult airway) 4) Pregnant or lactating females 5) Patients with known history of substance abuse 6) Patients with hypotension, bradycardia or pre existing heart block

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of Dexmedetomidine infusion on haemodynamic stability (Systolic and Diastolic Blood Pressure, Mean Arterial Pressure and Heart Rate) in response to the following events in patients undergoing laparoscopic cholecystectomy: laryngoscopy and endotracheal intubation, creation of pneumoperitoneum and extubation.Timepoint: Before starting infusion, 10 minutes after starting infusion, 1 minute after laryngoscopy and intubation, after pneumoperitoneum at- 1 minute, 15 minutes, 30 minutes, 45 minutes, 60 minutes and 1 minute after extubation	—

Measure

Time frame

To evaluate the effect of Dexmedetomidine infusion on haemodynamic stability (Systolic and Diastolic Blood Pressure, Mean Arterial Pressure and Heart Rate) in response to the following events in patients undergoing laparoscopic cholecystectomy: laryngoscopy and endotracheal intubation, creation of pneumoperitoneum and extubation.Timepoint: Before starting infusion, 10 minutes after starting infusion, 1 minute after laryngoscopy and intubation, after pneumoperitoneum at- 1 minute, 15 minutes, 30 minutes, 45 minutes, 60 minutes and 1 minute after extubation

—

Secondary

Measure	Time frame
To oberve the effects on analgesia in immediate post operative periodTimepoint: post operatively at 1 minute, 15 minutes, 30 minutes and 60 minutes after extubation;To observe the effects on level of sedation at the end of surgeryTimepoint: post operatively at 1 minute, 15 minutes, 30 minutes and 60 minutes after extubation;To record other relevant observations, if anyTimepoint: From the start of infusion at 10 minutes prior to induction of anaesthesia till 60 minutes after extubation	—

Measure

Time frame

To oberve the effects on analgesia in immediate post operative periodTimepoint: post operatively at 1 minute, 15 minutes, 30 minutes and 60 minutes after extubation;To observe the effects on level of sedation at the end of surgeryTimepoint: post operatively at 1 minute, 15 minutes, 30 minutes and 60 minutes after extubation;To record other relevant observations, if anyTimepoint: From the start of infusion at 10 minutes prior to induction of anaesthesia till 60 minutes after extubation

—

Countries

India

Contacts

Public ContactDr Aldiona S Bhattacharyya

Gauhati Medical College and Hospital

aldiona.shanpru1958@gmail.com9101813237

Outcome results

None listed

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