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Comparision of safety and efficacy of using less muscle relaxant and reversal versus TOF versus traditional muscle relaxant and reversal in laparoscopic gall bladder removal surgery

Comparison of safety and efficacy of restricted use of muscle relaxant and TOF (Train of Four) based reversal with conventional use of muscle relaxant and reversal in laparoscopic cholecystectomy: A Prospective randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092425
Enrollment
40
Registered
2025-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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: nil: nil Control Intervention1: Group F : Fixed dose group: will receive weight based dose of muscle relaxant atracurium with fixed dose of neostigmine Control Intervention2: Group Va

Sponsors

Singam Geetha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1-2 , 18-65 yr age, both gender, BMI :18.5 to 27 kg/m2, Duration of surgery: 1hr to 3 hr Elective surgery

Exclusion criteria

Exclusion criteria: A history of myopathy, polyneuropathy, Severe kidney or liver diseases, Thyroid disorders, Myasthenia or stroke, Patients treated with amino glycosides or magnesium or any medication known to influence neuromuscular function, Unexpected difficult airway, Pregnancy, breastfeeding, Emergency surgery, Chronic obstructive pulmonary disease, CAD, Electrolyte imbalance, Intra operative airway complication-bronchospasm and aspiration

Design outcomes

Primary

MeasureTime frame
1.Feasibility of providing adequate surgical conditions by maintaining entropy of 40-50 and without dense neuromuscular blockade. 2.Comparison of surgical conditions and atracurium requirement between use of liberal dose of atracurium to achieve dense neuromuscular block (group F) and restricted use of atracurium while maintain adequate depth of anesthesia (group V) 3.Comparison of dose of neostigmine for reversal of NMBD with a liberal dose of neostigmine administered based on clinical judgment with administration of neostigmine titrated to TOF ratio. Timepoint: intraop

Secondary

MeasureTime frame
1. Comparison of maximum intra abdominal pressure, peak airway pressure at highest intra abdominal pressure, airway Compliance at highest intra abdominal pressure, requirement of isoflurane, requirement of intraoperative fentanyl between the groups. 2. Comparison of TOF ratio at the time of decision of reversal and time for extubation, 3. Comparison of TOF ratio at extubation and in the post extubation period, 4. Comparison of postoperative pulmonary complications between the groups, 5. Comparison of VAS and RSS score between the groups, 6. Comparison of change in muscle grip strength and PEFR from baseline, time required to sit and stand between the groups. Timepoint: Intraop, postop 15min,1hr,,3hr and 24 hr

Countries

India

Contacts

Public ContactSingam Geetha

Nizams Institute of Medical Sciences

singamgeetha11@gmail.com09441043075

Outcome results

None listed

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