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Trial registered on ANZCTR


Registration number
ACTRN12614000805673
Ethics application status
Approved
Date submitted
6/04/2014
Date registered
30/07/2014
Date last updated
30/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of 0.8% sevoflurane versus Entonox for labour analgesia
Scientific title
Comparison of 0.8% sevoflurane versus Entonox for labour analgesia
Secondary ID [1] 284399 0
NMRR-14-139-19303

National Medical Research Registry, Malaysia
Universal Trial Number (UTN)
U1111-1155-4304
Trial acronym
SEVONOX Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Active Labour in healthy parturients 291582 0
Post analgesic nausea and vomiting 291583 0
Short term memory and amnesic effects of sevoflurane and entonox 292467 0
Condition category
Condition code
Anaesthesiology 291961 291961 0 0
Pain management
Reproductive Health and Childbirth 292925 292925 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of sevoflurane 0.8% and nitrous oxide 50% in oxygen for labour analgesia. Sevoflurane 0.8% will be administered as an inhalational agent using the Diamedica draw over vaporiser with a fixed concentration of 0.8% in air. Entonox will be administered via the Entonox inhaler attached to the hospital wall supply.

Both agents will be given as patient controlled inhalers throughout the duration of labour
Intervention code [1] 289136 0
Treatment: Drugs
Comparator / control treatment
Entonox (nitrous oxide 50% in 50% oxygen) as an inhalational agent via facemask and using the Entonox inhaler

Entonox will be given throughout the duration of labour
Control group
Active

Outcomes
Primary outcome [1] 291864 0
1) Overall pain experience
Timepoint [1] 291864 0
Noted at 1hr post delivery and at 24 hours post delivery using a Visual analogue scale (VAS)
Primary outcome [2] 292631 0
2) Pain score during labour
Timepoint [2] 292631 0
Hourly review of pain score using the VAS
Primary outcome [3] 292632 0
3) The need to use alternative analgesia
Timepoint [3] 292632 0
Other methods of analgesia required throughout labour
Secondary outcome [1] 307691 0
1) Maternal sedation score determined hourly through the labour experience
Timepoint [1] 307691 0
Hourly during labour using the Wilson Sedation scale
Secondary outcome [2] 309379 0
2) Blood pressure, heart rate and oxygen saturation

Timepoint [2] 309379 0
Monitored hourly throughout labour using a DINAMAP blood pressure monitor and pulse oximetry
Secondary outcome [3] 309380 0
3) Nausea and vomiting episodes in both categories of patients
Timepoint [3] 309380 0
Nausea will be monitored hourly via a VAS
Vomiting will be monitored as number of episodes per hour
Overall nausea and vomiting will be measured at the end of delivery using the PONV Intensity scoring
Secondary outcome [4] 309381 0
4) Amnesia rate of both categories
Timepoint [4] 309381 0
Done at end of delivery, assessed using picture recall method
Secondary outcome [5] 309382 0
5) Mode of delivery
Timepoint [5] 309382 0
Comparing if the choice of analgesia will affect the mode of delivery, spontaneous vaginal delivery, LSCS, Assisted vaginal delivery via vacuum or forceps
Secondary outcome [6] 309383 0
6) Blood loss
Timepoint [6] 309383 0
Estimated blood loss at end of delivery
Secondary outcome [7] 309384 0
7) Apgar score of baby
Timepoint [7] 309384 0
At end of delivery, to assess the effect of the intervention on the babies outcome.
Secondary outcome [8] 309554 0
Cord blood pH
Timepoint [8] 309554 0
At end of third stage of labour, to assess condition of baby

Eligibility
Key inclusion criteria
Healthy parturients in active labour with no medical or surgical comorbidities
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any coexisting medical or surgical comorbities to mother and fetus

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Trial explained and consent to participate in study obtained in antenatal clinic at 36weeks.

Upon presenting to the labour ward, the Patient is then reconsented and and randomised to either treatment arm.

Randomisation was done using a random number generator and the treatment arm is sealed in an opaque envelope and opened only upon randomisation

Patient will not be told which arm they are in. The investigators will not be blinded as the equipment to deliver the drug differs and is easily recognisable to the investigators. However our patients recruited would be exposed for the first time to such devices
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
From the paper by Yeo et al, pain relief score [median (range)]for sevoflurance was 67 (33-100) mm and Entonox 51([13-100)mm. Using the sample size calculator, OpenEpi; with power of 80% and significant level at 0.05, Median was approximate to mean, SD was calculated by using the formula of (max – min)/4;

Sample size 46; 23 in each arm

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
1/05/2014
Date of last participant enrolment
Anticipated
30/04/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment outside Australia
Country [1] 5967 0
Malaysia
State/province [1] 5967 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 289046 0
University
Name [1] 289046 0
University Of Malaya Research Grant
Country [1] 289046 0
Malaysia
Primary sponsor type
University
Name
University of Malaya
Address
University of Malaya,
Jalan Universiti
50603, Petaling Jaya
Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 287715 0
None
Name [1] 287715 0
Address [1] 287715 0
Country [1] 287715 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290843 0
Ethics Committee, University of Malaya Medical Centre
Ethics committee address [1] 290843 0
Jawatankuasa Etika Perubatan, Jabatan Kualiti
Bahagian Pengurusan Risiko,
Kompleks Pendidikan Sains Kejururawatan,
Tingkat 1, Menara Utama
Pusat Perubatan Universiti Malaya
Lembah Pantai, 59100, Kuala Lumpur
Ethics committee country [1] 290843 0
Malaysia
Date submitted for ethics approval [1] 290843 0
Approval date [1] 290843 0
20/09/2013
Ethics approval number [1] 290843 0
1017.42

Summary
Brief summary
Labour analgesia in the form of epidural would be ideal for all parturients but this being expensive to provide is limited in supply to only about 1% of the Malaysian population. Dose finding studies have shown that 0.8% sevoflurane administered to a parturient can provide substantial analgesia. A commercially available 0.8% inhaler has just emerged in the market. We would like to compare this method with the traditional option of using Entonox.

In this study we propose to compare the pain experience of parturients exposed to either 0.8% sevoflurane or entonox. We expect the 0.8% inhaler to provide better analgesia for the mother. We do not expect any untoward complications to arise from its use. The costing results will be unknown until after the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47558 0
Prof Chan Yoo Kuen
Address 47558 0
Department of Anaesthesia,
Faculty of Medicine,
University of Malaya,
50603, Kuala Lumpur
Malaysia
Country 47558 0
Malaysia
Phone 47558 0
+60379492052
Fax 47558 0
Email 47558 0
[email protected]
Contact person for public queries
Name 47559 0
Kevin Ng Wei Shan
Address 47559 0
Department of Anaesthesia,
Faculty of Medicine,
University of Malaya,
50603, Kuala Lumpur
Malaysia
Country 47559 0
Malaysia
Phone 47559 0
+60122987708
Fax 47559 0
Email 47559 0
[email protected]
Contact person for scientific queries
Name 47560 0
Chan Yoo Kuen
Address 47560 0
Department of Anaesthesia,
Faculty of Medicine,
University of Malaya,
50603, Kuala Lumpur
Malaysia
Country 47560 0
Malaysia
Phone 47560 0
+60379492052
Fax 47560 0
Email 47560 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23331Study protocol  [email protected]
23332OtherNg, K. W. S.1,*; Chan, Y.1; Shariffuddin, I. I.1; Yim, C. C. W.1; Md Latar, I. L.1; Eltringham, R.2; Moy, Y.1 Abstract PR210: Sevonox Study: A Comparison of 0.8% Sevoflurane & Entonox for Labour Analgesia, Anesthesia & Analgesia: September 2016 - Volume 123 - Issue 3S - p 271-272 doi: 10.1213/01.ane.0000492608.13239.1ehttps://journals.lww.com/anesthesia-analgesia/fulltext/2016/09002/abstract_pr210__sevonox_study__a_comparison_of.203.aspx[email protected] 366125-(Uploaded-27-07-2020-15-19-48)-Study-related document.pdf
23333OtherNg, K. W. S.1,*; Chan, Y.1; Shariffuddin, I. I.1; Yim, C. C. W.1; Md Latar, I. L.1; Eltringham, R.2; Moy, Y.1 Abstract PR210: Sevonox Study: A Comparison of 0.8% Sevoflurane & Entonox for Labour Analgesia, Anesthesia & Analgesia: September 2016 - Volume 123 - Issue 3S - p 271-272 doi: 10.1213/01.ane.0000492608.13239.1ehttps://journals.lww.com/anesthesia-analgesia/fulltext/2016/09002/abstract_pr210__sevonox_study__a_comparison_of.203.aspx[email protected] 366125-(Uploaded-27-07-2020-15-19-52)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Ng, K. W. S.1,*; Chan, Y.1; Shariffuddin, I. I.1; ... [More Details]

Documents added automatically
No additional documents have been identified.