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Comparison of time taken by two drugs - Sugammadex and Neostigmine to reverse the effect of vecuronium induced neuromuscular blockade in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia: a randomized clinical trial.

Comparison of Sugammadex and Neostigmine on the reversal of vecuronium induced neuromuscular blockade in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia- a randomized clinical trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096704
Enrollment
36
Registered
2025-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: - Health Condition 2: K801- Calculus of gallbladder with othercholecystitis

Interventions

Intervention1: Inj. Sugammadex 2mg/kg: Study participants will receive Inj. Sugammadex 2mg/kg diluted in 10mL normal saline for reversal of vecuronium induced neuromuscular blockade when four twitches

Sponsors

Regional Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of either sex-male or female 2. Patients of age group 18 to 60 years of Manipuri ethnicity undergoing elective laparoscopic cholecystectomy surgery under general anaesthesia. 3. Patients of American Society of Anesthesiologists (ASA) physical status grade I or II

Exclusion criteria

Exclusion criteria: 1. Patients not willing to participate 2. Patients with known allergy to any of the study drugs 3. Patients with known neuromuscular disease. 4. Patients with pre-existing respiratory, cardiovascular, hepatic or renal dysfunction. 5. Patients with suspected malignant hyperthermia 6. Pregnant and breastfeeding patients 7. Patient who had joined in any studies in the past one month.

Design outcomes

Primary

MeasureTime frame
1. Time taken from the start of administration of the study drugs (Sugammadex or Neostigmine-Glycopyrrolate) at appearance of fourth twitch of train of four stimulation till recovery of normalized TOF ratio of 0.9 or more. 2. Time to 5 secs head lift from the time of administration of the study drugs.Timepoint: 1. Time (mins) taken from the start of administration of the study drugs (Sugammadex or Neostigmine-Glycopyrrolate) at appearance of fourth twitch of train of four stimulation till recovery of normalized TOF ratio of 0.9 or more( single time point) 2. Time (mins) to 5 secs head lift from the start of administration of the study drugs( single time point).

Secondary

MeasureTime frame
1. Hemodynamic parameters such as blood pressure(BP) & heart rate (HR). 2. Incidences of train of four normalized ratio of less than 0.9 during the first hour of post-operative period.Timepoint: 1.Hemodynamic parameters such as BP & HR ( baseline, at 5min, 10mins, thereafter, every 10 mins until OT is done & every 15min till 1 hour of the post-operative period). 2.Incidences of train of four normalized ratio of less than 0.9 during the 1st hour of the post-operative period.

Countries

India

Contacts

Public ContactTAKHELMAYUM HEMJIT SINGH

Regional Institute of Medical Sciences

takhelhem@yahoo.com9436021445

Outcome results

None listed

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