Skip to content

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

Evaluate and compare the effects of intravenous dexmedetomidine and magnesium sulphate as adjunct to general anesthesia on perioperative haemodynamics variability in patient undergoing laparoscopic cholecystectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051448
Enrollment
69
Registered
2023-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Injection Magnesium sulphate: After arrival of patient to OT baseline vitalswill be recorded. Bispectral index (BIS) electrodes and TOF-Watch SX will be connected. A 18 or 20G periphe

Sponsors

Pt B. D. Sharma University Of Health Sciences, PGIMS,Rohtak, Haryana
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To compare the changes in HR & MAP during laryngoscopy and intubation, creation & release of pneumoperitoneum and extubation.Timepoint: 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

MeasureTime frame
To observe and compare intraoperative anaesthesia requirement, extubation time, time to first rescue analgesic requirement and postoperative sedationTimepoint: 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

Countries

India

Contacts

Public ContactDr Vaishali Gupta

Pt B. D. Sharma PGIMS, Rohtak

Vaishali.guptaa4@gmail.com9643709289

Outcome results

None listed

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