NCT02785653

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2016

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

2.6 years

First QC Date

May 25, 2016

Last Update Submit

June 7, 2016

Conditions

Muscle Relaxation Caused by Sevoflurane

Keywords

sevofluranerocuroniumintubation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • lag time

    10 minutes

  • onset time for maximum relaxation

    10 minutes

Study Arms (2)

sevoflurane and rocuronium

EXPERIMENTAL

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: SevofluraneDrug: Rocuronium

rocuronium

ACTIVE COMPARATOR

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

Interventions

SevofluraneDRUG

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

Also known as: Sevorane
sevoflurane and rocuronium
RocuroniumDRUG

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

Also known as: Esmeron
rocuroniumsevoflurane and rocuronium

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jaslok Hospital and Research Centre

Mumbai, Maharashtra, India

Location

MeSH Terms

Interventions

SevofluraneRocuronium

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Nazmeen I Sayed, DNB(Anaes)

    Lokmanya Tilak Municipal Medical College and Hospital

    PRINCIPAL INVESTIGATOR

  • Dipankar Dasgupta, MD(Anaes)

    Jaslok Hospital and Research Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor ,Department of Anaesthesia,Lokmanya Tilak Municipal Medical College and Hospital

Study Record Dates

First Submitted

May 25, 2016

First Posted

May 30, 2016

Study Start

April 1, 2004

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

June 9, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)