Effect of Sevoflurane on the Onset Characteristics and Intubating Conditions of Rocuronium

Phase 4

Completed

• Conditions: Muscle Relaxation Caused by Sevoflurane
• Interventions: Drug: Sevoflurane; Drug: Rocuronium

• Registration Number: NCT02785653
• Lead Sponsor: Maharashtra University of Health Sciences

Brief Summary

This study evaluates the potentiation of muscle relaxation caused by rocuronium by inhalational agent sevoflurane. Half the patients will be ventilated with oxygen ,nitrous oxide and sevoflurane during induction of anaesthesia and half will be ventilated only with oxygen and nitrous oxide.

Detailed Description

Rocuronium is a non depolarizing muscle relaxant. Inhalational general anaesthetic agents like Sevoflurane have some muscle relaxation effect by depressing the spinal motor neurons. Inhalational anaesthetics also alter the tonic input received from descending modulatory systems from the brain. Deep anaesthesia with inhalational agents may cause some degree of neuromuscular blockade.

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-05-27
• Study First Posted: 2016-05-30
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-07
• Last Update Posted: 2016-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• American society of anaesthesiologists physical status 1 and 2
• Age between 18-65
• Mallampatti classification 1 and 2

Exclusion Criteria

• Patients refusal to participate
• American society of anaesthesiologists physical status 3 and 4
• Mallampatti classification 3 and 4
• Patients with neuromuscular disorder
• Patients on medications that affect neuromuscular block
• Pregnant and lactating patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sevoflurane and rocuronium	Rocuronium	After induction of general anaesthesia, patients in the sevoflurane group were ventilated with fresh gas flow of 5 lites per minute consisting of 66.6% nitrous oxide and 33.3% oxygen with 2% inspired concentration of sevoflurane. After stabilization of end tidal carbondioxide to 30-35 mmHg ,intravenous rocuronium 0.6mg per Kg body weight was injected
sevoflurane and rocuronium	Sevoflurane	After induction of general anaesthesia, patients in the sevoflurane group were ventilated with fresh gas flow of 5 lites per minute consisting of 66.6% nitrous oxide and 33.3% oxygen with 2% inspired concentration of sevoflurane. After stabilization of end tidal carbondioxide to 30-35 mmHg ,intravenous rocuronium 0.6mg per Kg body weight was injected
rocuronium	Rocuronium	After induction of general anaesthesia, patients in the control group were ventilated with fresh gas flow of 5 lites per minute consisting of 66.6% nitrous oxide and 33.3% oxygen . After stabilization of end tidal carbondioxide to 30-35 mmHg ,intravenous rocuronium 0.6mg per Kg body weight was injected

Primary Outcome Measures

Name	Time	Method
intubating condition	10 minutes	Copenhagen Consensus Conference Scale-scale to assess ease of intubation consisting of 5 parameters.laryngoscopy,vocal cord movement,vocal cord position,movement at intubation,coughing at intubation all are judged as poor ,good or excellent.If any parameter has a poor score, it is a clinically unacceptable intubating condition.

Secondary Outcome Measures

Name	Time	Method
lag time	10 minutes	time from start of rocuronium injection to first change in single twitch height on neuromuscular monitor
onset time for maximum relaxation	10 minutes	time from start of rocuronium injection to the disappearance of all four twitches on train of four stimulus on neuromuscular monitor

Trial Locations

Locations (1)

Jaslok Hospital and Research Centre; 🇮🇳 Mumbai, Maharastra, India