Comparative study between Sugammadex and Neostigmine in reversing the neuromuscular blockade caused by Rocuronium under general anaesthesia

Phase 4

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2025/03/082137

Lead Sponsor: Chamarajanagar Institute of Medical Sciences

Brief Summary: 1) General Anaesthesia relies on neuromuscular blockade to improve airway management and surgical conditions. However, residual neuromuscular blockade has been linked to an increased risk of pulmonary complications after surgery. The introduction of quantitative neuromuscular monitoring devices in the 1970s rendered subjective clinical parameters for monitoring neuromuscular blockade nearly become obsolete.

2)Deep neuromuscular blockade can enhance surgical conditions during major abdominal procedures and reduce insufflation pressures in laparoscopic surgeries. However, it is important to note that deep neuromuscular blockade has been associated with potential complications such as prolonged postoperative muscle paralysis, residual neuromuscular blockade, hypoxemia, and atelectasis.

3)Non-depolarizing neuromuscular blockers like Rocuronium are frequently used to relax muscles during surgery and to aid ventilate the lungs in emergency and elective cases. It is one of the several non-depolarizing neuromuscular blockers that are employed, but it stands out for being reversible and fast-acting.

4)Traditionally, acetylcholinesterase inhibitors were commonly used to reverse the effects of nondepolarizing neuromuscular blocking agents. However, these inhibitors were not effective enough in reversing deep blockade and can cause residual neuromuscular blockade with some undesirable effects. A new reversal agent called Sugammadex has been developed, which works by encapsulating and reversing the effects of Rocuronium. This study is planned to assess the efficacy and safety of Sugammadex to reverse the effect of Rocuronium induced neuromuscular blockade in comparison with standard Neostigmine reversal for the same.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1)Patient willing to participate with written informed consent.
2)Patients belonging to ASA grade I and 2 of either sex.
3)Patient with age group between 18 to 70 years posted for elective surgeries under General Anaesthesia.

Exclusion Criteria

1)Known allergy to any of study drugs 2)Pregnancy and Lactation 3)Patients with history of high dose steroid intake 4)Patients with known Cardiac disorders/Respiratory illnesses/Endocrine disorders 5)Patients with known history of Renal dysfunction/Hepatic dysfunction 6)Patients who are suspected to have Neuromuscular disorders.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the time taken for neuromuscular recovery between Sugammadex reversal and Neostigmine reversal for Rocuronium induced neuromuscular blockade as indicated by TOF monitoring	Time taken for the reversal till TOF ratio of 0.9 is achieved.

Secondary Outcome Measures

Name	Time	Method
To study hemodynamic changes between two groups of patients.	Intraoperatively and After extubation patient was monitered for any hemodynamic variability

Trial Locations

Locations (1): Chamarajanagar Institute of Medical University
🇮🇳
Chamarajanagar, KARNATAKA, India
Chamarajanagar Institute of Medical University
🇮🇳Chamarajanagar, KARNATAKA, India
Dr Kapadam Pavan Sai Kumar Reddy
Principal investigator
8919973398
pavansaikumarreddy@gmail.com