To compare the effects of intravenous dexmedetomidine and magnesium sulphate given in addition to general anaesthesia on perioperative haemodynamics in patients undergoing laparoscopic cholecystectomy

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/04/051448
• Lead Sponsor: Pt B. D. Sharma University Of Health Sciences, PGIMS,Rohtak, Haryana

Brief Summary

This study is to investigate the effect of dexmedetomidine and magnesium sulphate used as adjunct to general anaesthesia on perioperative haemodynamic response to laryngoscopy, intubation, pneumoperitoneum and extubation in patients undergoing laparoscopic cholecystectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-30
• Study Completion: 2024-01-30
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

American society of Anesthesiology grade I and II between the age of 18-65 years, of either sex and posted for laparoscopic cholecystectomy under general anaesthesia.

Exclusion Criteria

• Patients with major hepatic, renal and endocrine dysfunction, cardiovascular dysfunction; neuromuscular, neurological disorder, atrioventricular conduction disturbance, COPD, asthma, obstructive sleep apnea and haematological disorders.
• Patients with difficult airway.
• Patients with known allergy to dexmedetomidine or magnesium sulphate.
• Pregnancy, obesity (body mass index>30 kg m-2), hypertension, diabetes mellitus, and major systemic illness Patients on treatment with calcium channel blockers, beta-blockers, alpha 2 adrenergic agonists or opioid abuse Any intraoperative surgical complication like prolonged surgery (duration more than two hours) or conversion to open surgery, Patient’s unwillingness to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the changes in HR & MAP during laryngoscopy and intubation, creation & release of pneumoperitoneum and extubation.	T0 baseline data | T1 following completion of study drug infusion | T2 1 minute after induction | T3 1 minute after intubation | T4 after peritoneal insufflation | T5 15 min after peritoneal insufflation T6 after peritoneal deflation | T7 1 min after extubation | T8 60 min after extubation

Secondary Outcome Measures

Name	Time	Method
To observe and compare intraoperative anaesthesia requirement, extubation time, time to first rescue analgesic requirement and postoperative sedation	Intraop requirement of total propofol, fentanyl, muscle relaxant and mean end tidal sevoflurane concentration ;Extubation time; Duration of surgery; Time to first rescue analgesia- time from extubation to time when pain reported by patient was ≥4 on visual analogue scale. Injection paracetamol l5mg/kg IV will be used ,If the patient doesn’t get relief in 15 min Injection diclofenac 1.5mg/kg will be given; Post op sedation level will be assessed at 1,15,30, 60 min using Ramsay sedation score

Trial Locations

Locations (1)

Pt B. D. Sharma , PGIMS; 🇮🇳 Rohtak, HARYANA, India

Pt B. D. Sharma , PGIMS

🇮🇳Rohtak, HARYANA, India

Dr Vaishali Gupta

Principal investigator

9643709289

Vaishali.guptaa4@gmail.com