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

NCT ID: NCT02785653

Last Updated: 2016-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-11-30

Brief Summary

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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

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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.

Conditions

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Muscle Relaxation Caused by Sevoflurane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type 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

Rocuronium

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Rocuronium

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Rocuronium

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

Intervention Type DRUG

Other Intervention Names

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Sevorane Esmeron

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jaslok Hospital and Research Centre

OTHER

Sponsor Role collaborator

Maharashtra University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Nazmeen Sayed

Assistant Professor ,Department of Anaesthesia,Lokmanya Tilak Municipal Medical College and Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nazmeen I Sayed, DNB(Anaes)

Role: PRINCIPAL_INVESTIGATOR

Lokmanya Tilak Municipal Medical College and Hospital

Dipankar Dasgupta, MD(Anaes)

Role: STUDY_DIRECTOR

Jaslok Hospital and Research Centre

Locations

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Jaslok Hospital and Research Centre

Mumbai, Maharashtra, India

Site Status

Countries

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India

Other Identifiers

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PR/ANAES/C/61

Identifier Type: -

Identifier Source: org_study_id

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