Trial for comparison of commonly used drug to the drug plus Calcium gluconate for measuring speed of recovery from muscle relaxant

Not yet recruiting

• Conditions: Disease of digestive system, unspecified,

• Registration Number: CTRI/2020/07/026726
• Lead Sponsor: Armed Forces Medical Research Comittee

Brief Summary

Muscle relaxation is theintegral part of general anaesthesia for intubation in elective surgeries.  Few studies are published regarding the roleof using calcium with reversal agents for faster recovery in adults only but thereis paucity of studies in pediatric group. After ethical clearance the plan isto compare the effects of addition of calcium gluconate to the reversal agenton the basis of train of four and BIS monitoring.. Using BIS monitoring for thedepth of anaesthesia will be useful to avoid the bias due to the depth ofanaesthesia.

After completion of surgery, as TOFc-4 (Trainof Four count) is achieved, patients will receive 70 µg/kg neostigmine and20µg/kg glycopyrrolate. Calcium gluconate 5mg/kg will be given with neostigmineand glycopyrrolate in the calcium group and normal saline in the control group.Duration of recovery between giving the reversal agent and the train of fourratio of 90 will be noticed and then compared.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-07-15
• Study Start: 2020-08-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Patients between age of 3 to 15 years 2.ASA I and II.

Exclusion Criteria

• 1.Suspected difficult airway 2.
• History of bronchial asthma, neuromuscular disease, hepatic or renal disease.
• Clinically suspected hypercalcemia 4.
• Severe or significant congenital heart disease 5.Bleeding diathesis 6.History of allergies to glycopyrrolate or neostigmine 7.Parental refusal 8.
• Weight of less than 10 kg.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration between injecting reversal agent and TOFr more than 90%	3,5 and 10 min

Secondary Outcome Measures

Name	Time	Method
Post operative Recurarisation at 3,5 and 10 min interval of giving the reversal agent	3,5 and 10 min

Trial Locations

Locations (1)

Command Hospital Western Command; 🇮🇳 Panchkula, HARYANA, India

Command Hospital Western Command

🇮🇳Panchkula, HARYANA, India

Gunjan Singh

Principal investigator

09612112136

gunjanafmc@gmail.com