Study of Injection Sugammadex after muscle relaxation agents in Cardiac Catheterisation Laboratory

Not yet recruiting

• Conditions: Congenital malformations of the circulatory system, (2) ICD-10 Condition: I00-I99||Diseases of the circulatory system,

• Registration Number: CTRI/2023/06/053360
• Lead Sponsor: Institutional Research Society

Brief Summary

Muscle relaxation isa core component of anaesthesia which helps facilitate endotracheal intubationand provides optimal surgical operating conditions.

Anaesthetists haveaccess to a wide variety of Neuromuscular blocking agents (NMBAs) for thispurpose. Following surgery, relaxation is no longer needed, hence it is importantthat effects of the NMBAs be quickly and effectively terminated. Residualneuromuscular blockade after surgery has been associated with adverse patientoutcomes including airway obstruction, hypoxia, respiratory complications, andsymptoms of muscle weakness and dyspnea.Theuse of neuromuscular blockade, especially without reversal, has been associatedwith an increased risk of postoperative pneumonia.

Cath lab procedureslike percutaneous trans-catheter device closure procedures are nowadays aroutine treatment of cardiac lesions like septal defects, ruptured sinus ofvalsalva .Most of these procedures are done under generalanaesthesia with the muscle relaxation and maintenance with inhalational agentslike sevoflurane to ensure precision of catheter movements during procedures.The duration of action of NMBs in this group of patients are prolonged becauseof low ambient temperature and altered cardiovascular physiology and there isan added risk of recurarization in these patients after reversal and shiftingto PACU. Hence this represents a group of patients where quick and effectivereversal at the end of the procedure can facilitate earlier extubation andreduced post operative pulmonary complications.The added advantages of reducedICU stay becomes very relevant in our Cath lab which has a very high turnoverrate. Hence Sugammadex if proven to be quicker in onset and more effective canreplace the current reversal agent Neostigmine thus helping in faster reversalof neuromuscular blockade and better patient care.

Therefore, we plan toconduct a randomized-controlled trial to compare the efficacy and safety ofsugammadex and neostigmine with respect to reversal of moderate NMB (fromre-appearance of second twitch to Train Of Four ratio >0.9) in patientsundergoing cath lab procedures under general anaesthesia. Our secondaryoutcomes will be to detect the occurrence of adverse events if any and time takento PACU discharge readiness using the modified Aldrete score with sugammadexcompared to neostigmine groups.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-05-26
• Study Start: 2023-10-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• ASA grade I-IV patients.
• Age between 20 and 60 years.
• Patients posted for elective cardiac catheterisation procedures in the cathlab.
• Availability of informed consent and willingness of the patient to be a part of the study.

Exclusion Criteria

• Patients requiring emergency surgery.
• Incapacity to consent 3.
• Patient with renal, hepatic and pre-existing pulmonary comorbidities.
• Patients allergic to Sugammadex, neostigmine or glycopyrrolate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Our primary outcome is to note the time(in minutes) from re-appearance of second twitch to TOF ratio more than 0.9 with sugammadex compared to neostigmine groups. This is a parameter to measure the efficacy of the study drugs.	Baseline, Just before extubation

Secondary Outcome Measures

Name	Time	Method
to detect the occurrence of any adverse events after administration of study drug	2 hours, 4 hours, 6 hours, 8 hours
2)To measure the time to PACU discharge readiness using the modified Aldrete score in both the study groups.	two hours after shifting to icu,

Trial Locations

Locations (1)

KEM hospital Catheter lab; 🇮🇳 Mumbai, MAHARASHTRA, India

KEM hospital Catheter lab

🇮🇳Mumbai, MAHARASHTRA, India

Dr Sanjeeta Umbarkar

Principal investigator

9323273435

sanjeeta69@yahoo.com