Effect of Sevoflurane on the Onset Characteristics and Intubating Conditions of Rocuronium (SRI)

Effect of Sevoflurane on the Onset Characteristics and Intubating Conditions of Rocuronium Under Routine Clinical Practice

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.

Study Overview

• Status: Completed
• Conditions: Muscle Relaxation Caused by Sevoflurane
• Intervention / Treatment: Drug: Sevoflurane; Drug: Rocuronium

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Maharastra
    • Mumbai, Maharastra, India
      • Jaslok Hospital and Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: sevoflurane and 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	Drug: Sevoflurane; Patients were ventilated with 2 % inspired concentration of sevoflurane in a fresh gas flow of 5 litres containing 66.6% nitrous oxide and 33.3% percent of oxygen; Other Names: Sevorane; Drug: Rocuronium; rocuronium 0.6mg per kg body weight was given intravenously after induction of anaesthesia; Other Names: Esmeron
ACTIVE_COMPARATOR: 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	Drug: Rocuronium; rocuronium 0.6mg per kg body weight was given intravenously after induction of anaesthesia; Other Names: Esmeron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intubating condition	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.	10 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Maharashtra University of Health Sciences
• Collaborators: Jaslok Hospital and Research Centre
• Investigators: Principal Investigator: Nazmeen I Sayed, DNB(Anaes), Lokmanya Tilak Municipal Medical College and Hospital; Study Director: Dipankar Dasgupta, MD(Anaes), Jaslok Hospital and Research Centre

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (ACTUAL): November 1, 2006
• Study Completion (ACTUAL): November 1, 2006

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: May 27, 2016
• First Posted (ESTIMATE): May 30, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 9, 2016
• Last Update Submitted That Met QC Criteria: June 7, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: sevoflurane; intubation; rocuronium
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Sevoflurane; Rocuronium
• Other Study ID Numbers: PR/ANAES/C/61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO