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Use of Sugammadex as a reversal agent for neuromuscular blocking agent in patients undergoing neurosurgery.

A comparative study of Efficacy of 2mg/kg Sugammadex in reversing profound neuromuscular blockade with infusion of Rocuronium and Vecuronium in neurosurgical patients. - Nil

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062363
Enrollment
60
Registered
2024-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: S069- Unspecified intracranial injury

Interventions

Intervention1: Profound blockade by Inj VECURONIUM will be reversed with Sugammadex at end of surgery.: Profound blockade by Inj vecuronium Intravenous INFUSION in a dose of 0.03-0.07 MG/KG/HOUR as a

Sponsors

DR SUMEDHA MEHTA
Lead Sponsor
DR KIRTI PAWAR
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: -PATIENTS UNDERGOING ELECTIVE NEUROSURGICAL PROCEDURE UNDER GENERAL ANESTHESIA WITH SEVOFLURANE REQUIRING MUSCLE RELAXATION. -ASA PHYSICAL STATUS 1,2 AND 3.

Exclusion criteria

Exclusion criteria: 1) DIFFICULT AIRWAY. 2) NEUROMUSCULAR DISORDER THAT COULD IMPAIR NMB. 3) SIGNIFICANT RENAL OR HEPATIC DYSFUNCTION. 4) FAMILY HISTORY OF MALIGNANT HYPERTHERMIA. 5) PATIENTS RECEVING MEDICATIONS,WHICH INTERFER WITH THE NMBA. 6) PATIENTS REQUIRING POST-OPERATIVE VENTILATOR SUPPORT. 7) ALREADY INTUBATED OR TRACHEOSTOMIZED PATIENTS. 8) OBESITY. 9) PATIENT REFUSAL. 10) PREGNANT OR LACTATING WOMEN. 11) ANY ALLERGY TO STUDY DRUG.

Design outcomes

Primary

MeasureTime frame
2MG/KG DOSE OF SUGAMMADEX IS EFFECTIVE IN REVERSING PROFOUND NEUROMUSCULAR BLOCKADE WITH INFUSION OF ROCURONIUM AND VECURONIUM IN NEUROSURGICAL PATIENTS.Timepoint: TOF MONITORING: -PRIOR TO INDUCTION -IMMEDIATE AFTER INDUCTION -IMMEDIATE AFTER INTUBATION AND AT TIME INTERVAL OF 5 MINUTES -AT THE TIME OF EXTUBATION -5 AND 10 MIN AFTER EXTUBATION

Secondary

MeasureTime frame
ADVERSE EFFECTS ASSOCIATED WITH SUGAMMADEX.Timepoint: INTRA-OPERATIVELY AND POST-OPERATIVELY

Countries

India

Contacts

Public ContactKIRTI SURENDRA PAWAR

SMT KASHIBAI NAVALE MEDICAL COLLEGE,NARHE PUNE

Kirtipawar.95@gmail.com8390602541

Outcome results

None listed

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