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Trial record 32 of 659 for:    Sevoflurane

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

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ClinicalTrials.gov Identifier: NCT02785653
Recruitment Status : Completed
First Posted : May 30, 2016
Last Update Posted : June 9, 2016
Sponsor:
Collaborator:
Jaslok Hospital and Research Centre
Information provided by (Responsible Party):
Nazmeen Sayed, 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.

Condition or disease Intervention/treatment Phase
Muscle Relaxation Caused by Sevoflurane Drug: Sevoflurane Drug: Rocuronium Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Sevoflurane on the Onset Characteristics and Intubating Conditions of Rocuronium Under Routine Clinical Practice
Study Start Date : April 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine


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 Name: Sevorane

Drug: Rocuronium
rocuronium 0.6mg per kg body weight was given intravenously after induction of anaesthesia
Other Name: 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 Name: Esmeron




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785653


Locations
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India
Jaslok Hospital and Research Centre
Mumbai, Maharastra, India
Sponsors and Collaborators
Maharashtra University of Health Sciences
Jaslok Hospital and Research Centre
Investigators
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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

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Responsible Party: Nazmeen Sayed, Assistant Professor ,Department of Anaesthesia,Lokmanya Tilak Municipal Medical College and Hospital, Maharashtra University of Health Sciences
ClinicalTrials.gov Identifier: NCT02785653     History of Changes
Other Study ID Numbers: PR/ANAES/C/61
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nazmeen Sayed, Maharashtra University of Health Sciences:
sevoflurane
rocuronium
intubation

Additional relevant MeSH terms:
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Sevoflurane
Nitrous Oxide
Rocuronium
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents