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Completed

NCT Number: NCT02785653

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

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.

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Key information

Conditions

Muscle Relaxation Caused by Sevoflurane

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jaslok Hospital and Research Centre

Mumbai, Maharashtra, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

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

Rocuronium

Drug

rocuronium 0.6mg per kg body weight was given intravenously after induction of anaesthesia

Other names: Esmeron

Primary outcomes

  1. intubating condition

    Time frame: 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 outcomes

  1. lag time

    Time frame: 10 minutes

    time from start of rocuronium injection to first change in single twitch height on neuromuscular monitor

  2. onset time for maximum relaxation

    Time frame: 10 minutes

    time from start of rocuronium injection to the disappearance of all four twitches on train of four stimulus on neuromuscular monitor

Sponsors and collaborators

Lead sponsor

Maharashtra University of Health Sciences

Other

Collaborators

  • Jaslok Hospital and Research Centre

Registry information

Official study title

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

Acronym: SRI

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
May 30, 2016
Registry last updated
Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.