A clinical trial to study the effect of single dose of dexmedetomidine on blood pressure and heart rate during gall bladder surgery by endoscope under general anaesthesia

Completed

• Conditions: haemodynamic stress response during pneumoperitoneum

• Registration Number: CTRI/2017/07/009106
• Lead Sponsor: University College of Medical Sciences and Guru Teg Bahadur Hospital

Brief Summary

This randomized double-blind trial studied the effect of singledose of injection dexmedetomidine to control the haemodynamic response during CO2 pneumoperitoneum inpatients undergoing laparoscopic cholecystectomy under general anaesthesia. Patientsof test group received injection dexmedetomidine 1µg/kg given IV slow after induction of anaesthesia butbefore creation of CO2 pneumoperitoneum.  Patients of control group received normalsaline. All patients were monitored for ECG, HR, NIBP and SpO2. Postoperatively,sedation and pain were evaluated. During pneumoperitoneum, bloodpressure was significantly lower in dexmedetomidine group as compared tocontrol group. Intraoperative requirement of isoflurane and postoperative VASscore were significantly lower in the dexmedetomidine group. Sedation score inthe two groups was comparable after 30 minutes postoperatively.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-15
• Study Completion: 2014-03-24
• Last Update Posted: 2017-07-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Patients scheduled for elective laparoscopic cholecystectomy under general anaesthesia.
• 2.Belonging to ASA class I.

Exclusion Criteria

• 1.History of cardiovascular diseases e.g. hypertension, ischaemic heart disease, conduction defects, etc.
• 2.History of compromised renal / hepatic / neuronal functions.
• 3.Pregnant or lactating women.
• 4.Patient on any drug affecting cardiovascular parameters e.g. calcium-channel blockers, β-blockers, magnesium sulphate etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of isoflurane required to maintain MAP within ± 20% of its baseline values in both groups	After tracheal intubation every 10 minutes till the end of surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative sedation score (using Ramsay Sedation Scale)	After surgery, every 30 minutes till 2 hours and every 2 hours thereafter till 6 hours
Requirement of analgesic and anti-emetic in the two groups	After surgery till 6 hours

Trial Locations

Locations (1)

UCMS and GTB Hospital; 🇮🇳 East, DELHI, India

UCMS and GTB Hospital

🇮🇳East, DELHI, India

Dr Mahendra Kumar

Principal investigator

9868399709

mahendramohit@yahoo.com