Muscle Relaxation Caused by SevofluranePhase 4SRINCT02785653
Effect of Sevoflurane on the Onset Characteristics and Intubating Conditions of Rocuronium
A Phase 4 study testing Sevoflurane and Rocuronium in people with Muscle Relaxation Caused by Sevoflurane, run by Maharashtra University of Health Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Muscle Relaxation Caused by Sevoflurane
- What is being tested?
- Sevoflurane and Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2004to Nov 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American society of anaesthesiologists physical status 1 and 2
- Age between 18-65
- Mallampatti classification 1 and 2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Relaxation Caused by Sevoflurane
- Being tested
- Sevoflurane, Rocuronium
- Keywords
- sevoflurane, rocuronium, intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevorane
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
RocuroniumDrug
Also called Esmeron
rocuronium 0.6mg per kg body weight was given intravenously after induction of anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Sevoflurane; Drug: 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 Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (2)
lag time
time from start of rocuronium injection to first change in single twitch height on neuromuscular monitor
Measured: 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
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startApr 2004
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Relaxation Caused by SevofluraneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharashtra University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Jaslok Hospital and Research Centre
- Responsible party
- Principal investigator, Nazmeen Sayed, Maharashtra University of Health Sciences
- Investigators
- Nazmeen I Sayed, DNB(Anaes), Principal investigator, Lokmanya Tilak Municipal Medical College and HospitalDipankar Dasgupta, MD(Anaes), Study director, Jaslok Hospital and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785653
- Sponsor's protocol ID
- PR/ANAES/C/61
- Acronym
- SRI
- Status last verified
- Jun 2016
- First submitted
- 25 May 2016
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sevoflurane on the Onset Characteristics and Intubating Conditions of Rocuronium Under Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT02785653
- Acronym / sponsor ID
- SRI / PR/ANAES/C/61
- Conditions
- Muscle Relaxation Caused by Sevoflurane
- Keywords
- sevoflurane, rocuronium, intubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maharashtra University of Health SciencesUniversity, hospital or other
- Collaborators
- Jaslok Hospital and Research Centre
- Study start
- Apr 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 30 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sevoflurane and rocuronium | Experimental | Drug: Sevoflurane, Drug: RocuroniumAfter 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 |
| rocuronium | Active comparator | Drug: RocuroniumAfter 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American society of anaesthesiologists physical status 1 and 2
- Age between 18-65
- Mallampatti classification 1 and 2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneAlso: SevoranePatients 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 | Drug | sevoflurane and rocuronium |
| RocuroniumAlso: Esmeronrocuronium 0.6mg per kg body weight was given intravenously after induction of anaesthesia | Drug | rocuronium, sevoflurane and rocuronium |
Primary outcome
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.
2 secondary outcomes
lag time
Time frame: 10 minutes
onset time for maximum relaxation
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazmeen I Sayed, DNB(Anaes) principal investigator
Lokmanya Tilak Municipal Medical College and Hospital
Dipankar Dasgupta, MD(Anaes) study director
Jaslok Hospital and Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane and Rocuronium in people with Muscle Relaxation Caused by Sevoflurane, run by Maharashtra University of Health Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intubating condition (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.