A study comparing how well two different doses of Sugammadex work versus Neostigmine to help patients regain muscle strength after anesthesia during Laparoscopic Gallbladder removal surgery.

Comparison Of Efficacy Of Two Doses Of Sugammadex (1mg/kg and 2mg/kg) With Neostigmine(0.05mg/kg) For Reversal Of Rocuronium Induced Neuromuscular Blockade At Train-Of-Four Count Of Four In Patients Undergoing Laparoscopic Cholecystectomy Surgery: A Prospective, Randomised, Double-Blind Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/098137

Enrollment

102

Registered

2025-11-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis Health Condition 2: K800- Calculus of gallbladder with acutecholecystitis Health Condition 3: K810- Acute cholecystitis Health Condition 4: K811- Chronic cholecystitis Health Condition 5: K812- Acute cholecystitis with chronic cholecystitis Health Condition 6: K819- Cholecystitis, unspecified Health Condition 7: K801- Calculus of gallbladder with othercholecystitis Health Condition 8: K820- Obstruction of gallbladder

Interventions

Intervention1: Sugammadex: Sugammadex (1 milligram/kg) administered as a single Intravenous bolus over 10 30 seconds at the time when the patient demonstrates a Train-of-Four (TOF) count of 4 during r

Eligibility

Inclusion criteria

Inclusion criteria: Subject willing to participate BMI 18.5 to 25kg/m2 American Society of anesthesiologist (ASA) physical status classification score I to III Patients receiving Rocuronium for Neuromuscular blockade.

Exclusion criteria

Exclusion criteria: Patient refusal. ASA > III, Pregnancy, Lactation, BMI >25Kg/m2. Patients with inadequate Left Ventricular Ejection Fraction (Ejection Fraction Valvular or Ischemic Heart Disease, Uncontrolled Hypertension, Heart blocks, Arrhythmia, Cardiac failure, Uncontrolled Diabetes mellitus. Coexisting medical comorbidities like Hepatic, Renal, Endocrine, Haematological, Autoimmune, Psychiatric, Neurological diseases, Neuromuscular diseases, Bronchial asthma, Chronic Obstructive Pulmonary Disease. Allergy to study drugs. Patients receiving Atracurium and Cisatracurium. Suspected malignant hyperthermia.

Design outcomes

Primary

Measure	Time frame
To assess the time taken for recovery from neuromuscular blockade measured as Time (min) to achieve Train of four ratio (TOFr) = 0.9 after the administration of reversal agent.Timepoint: upto 15 minutes	—

Secondary

Measure	Time frame
I. Time to achieve sustained head lift more than or equal to 5 secs and Time to extubation after administration of reversal agent (other recovering criteria). II. Incidence of incomplete reversal (If normalized TOF ratio 0.9 will not reach within 15 mins after the reversal drug injection). III. Drug adverse effects related to reversal agent. IV. Incidence of reparalysis.( normalised train of four ratio less than 0.9). Timepoint: after reversal 2,5,10,20,30 mins.	—

Measure

Time frame

I. Time to achieve sustained head lift more than or equal to 5 secs and Time to extubation after administration of reversal agent (other recovering criteria). II. Incidence of incomplete reversal (If normalized TOF ratio 0.9 will not reach within 15 mins after the reversal drug injection). III. Drug adverse effects related to reversal agent. IV. Incidence of reparalysis.( normalised train of four ratio less than 0.9). Timepoint: after reversal 2,5,10,20,30 mins.

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Countries

India

Contacts

Public ContactDr Kumar T

R.N.T MEDICAL COLLEGE

dr.rgehlot.2010@gmail.com9468694902

Outcome results

None listed

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