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comparison of time taken to reverse the action of neuromuscular relaxant used during general anesthesia by sugammadex a novel drug with neostigmine-glycopyrrolate which is time tested drug

A prospective, randomized,double blinded study to compare the efficacy of sugammadex & neostigmine-glycopyrrolate for reversal of rocuronium induced neuromuscular blockage under sevoflurane anesthesia. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055309
Enrollment
100
Registered
2023-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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: total duration of study is 6 months. Control Intervention1: comparing the efficacy of sugammadex and neostigmine-glycopyrrolate for reversal of rocuronium induced neuromuscular blo

Sponsors

P. D. Hinduja National Hospital and Medical Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All elective surgeries under general anesthesia, with anticipated surgical time of 2 to 3 hours. 2. ASA Grade I and II patients.

Exclusion criteria

Exclusion criteria: 1.Patient refusal. 2.Renal dysfunction. 3.Hepatic dysfunction. 4.Patients with expected difficult intubation. 5.Those receiving medication like amikacin, bacitracin, phenytoin, aminoglycosides, polymyin B which interact with rocuronium. 6.Allergy to muscle relaxants or other drug used during anesthesia. 7.Female patients who are pregnant or breast feeding. 8.Cognitive impairment. 9.Patient with psychiatric disease. 10.Incomplete or unreliable history/clinical data. 11.Patients on beta blockade.

Design outcomes

Primary

MeasureTime frame
To measure the efficacy of sugammadex compared to neostigmine by comparing the time of extubation after administering the reversal drugs in rocuronium induced neuromuscular blockage under sevoflurane. Timepoint: 1using neuromuscular Monitoring measuring the time taken to achieve tof count of 0.7,0.8,0.9 and time of extubation—

Secondary

MeasureTime frame
To record the hemodynamic changes, if any, with the use of either sugammadex or neostigmine glycopyrrolate combination side effects profile of sugammadexTimepoint: 1. To measure hemodynamic stability measuring NIBP,pulse,spo2 & respiratory rate at before extubation, after extubation, 1,2,3,4,5,10,15,30,45,and 60min after extubation 2.any adverse event in post operative period—

Countries

India

Contacts

Public ContactDr Sonam Gupta

P.D Hinduja national hospital and medical research centre

dranjalipingle@gmail.com9833733915

Outcome results

None listed

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