ANZCTR - Registration

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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]

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

Post analgesic nausea and vomiting

Short term memory and amnesic effects of sevoflurane and entonox

Condition category

Condition code

Anaesthesiology

Pain management

Reproductive Health and Childbirth

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]

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]

1) Overall pain experience

Timepoint [1]

Noted at 1hr post delivery and at 24 hours post delivery using a Visual analogue scale (VAS)

Primary outcome [2]

2) Pain score during labour

Timepoint [2]

Hourly review of pain score using the VAS

Primary outcome [3]

3) The need to use alternative analgesia

Timepoint [3]

Other methods of analgesia required throughout labour

Secondary outcome [1]

1) Maternal sedation score determined hourly through the labour experience

Timepoint [1]

Hourly during labour using the Wilson Sedation scale

Secondary outcome [2]

2) Blood pressure, heart rate and oxygen saturation

Timepoint [2]

Monitored hourly throughout labour using a DINAMAP blood pressure monitor and pulse oximetry

Secondary outcome [3]

3) Nausea and vomiting episodes in both categories of patients

Timepoint [3]

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]

4) Amnesia rate of both categories

Timepoint [4]

Done at end of delivery, assessed using picture recall method

Secondary outcome [5]

5) Mode of delivery

Timepoint [5]

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]

6) Blood loss

Timepoint [6]

Estimated blood loss at end of delivery

Secondary outcome [7]

7) Apgar score of baby

Timepoint [7]

At end of delivery, to assess the effect of the intervention on the babies outcome.

Secondary outcome [8]

Cord blood pH

Timepoint [8]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Kuala Lumpur

Funding & Sponsors

Funding source category [1]

University

Name [1]

University Of Malaya Research Grant

Address [1]

Faculty of Medicine,
University of Malaya,
Jalan Universiti
50603, Petaling Jaya
Kuala Lumpur

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee, University of Malaya Medical Centre

Ethics committee address [1]

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]

Malaysia

Date submitted for ethics approval [1]

Approval date [1]

20/09/2013

Ethics approval number [1]

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

Prof Chan Yoo Kuen

Address

Department of Anaesthesia,
Faculty of Medicine,
University of Malaya,
50603, Kuala Lumpur
Malaysia

Country

Malaysia

Phone

+60379492052

Fax

[email protected]

Contact person for public queries

Name

Dr Kevin Ng Wei Shan

Address

Department of Anaesthesia,
Faculty of Medicine,
University of Malaya,
50603, Kuala Lumpur
Malaysia

Country

Malaysia

Phone

+60122987708

Fax

[email protected]

Contact person for scientific queries

Name

Prof Chan Yoo Kuen

Address

Department of Anaesthesia,
Faculty of Medicine,
University of Malaya,
50603, Kuala Lumpur
Malaysia

Country

Malaysia

Phone

+60379492052

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Attachment
23331	Study protocol			[email protected]
23332	Other	Ng, 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.0000492608.13239.1e	https://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
23333	Other	Ng, 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.0000492608.13239.1e	https://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

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4470	Study results article	Yes		Ng, K. W. S.1,*; Chan, Y.1; Shariffuddin, I. I.1; ... [More Details]

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Trial Review

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