ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12615000505505

Ethics application status

Approved

Date submitted

20/03/2015

Date registered

20/05/2015

Date last updated

12/02/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

The Relationship between Sleep Quality and Target Effect-site Propofol Concentration during Transvaginal Oocyte Retrieval

Scientific title

The Relationship between Sleep Quality and Target Effect-site Propofol Concentration of Target-Controlled Infusion in Adult Female Patients Receiving Transvaginal Oocyte Retrieval

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1168-5080

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sleep quality

Propofol required during Transvaginal Oocyte Retrieval

Condition category

Condition code

Anaesthesiology

Anaesthetics

Reproductive Health and Childbirth

Fertility including in vitro fertilisation

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

For the female adult patients who receive transvaginal oocyte retrieval, we use propofol target-controlled infusion as sedation. The initial TCI effect-site concentrations of propofol (Ceprop) was set at 4.0 microgram/ml and Ceprop was adjusted in steps of 0.2 microgram/ml to keep Entropy value at between 40 and 60. The propofol infusion begin before the insertion of the ultrasound probe and stopped when the probe was removed from the vagina. Later, the patients were assigned to two groups based on the result of Pittsburgh Sleep Quality Index. Patients with total score less than or equal to 5 was included in the group of good sleep quality and total score greater than 5 was assigned to the group of poor sleep quality. The data collected will be analyzed to decide whether poor sleep quality results in low target effect-site propofol concentration required for adequate sedation during transvaginal oocyte retrieval or not.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Relationship between sleep quality measured by using Pittsburgh Sleep Quality Index and the TCI effect-site concentrations of propofol required for loss of consciousness (loss of response to verbal commands) recorded by TCI device.

Timepoint [1]

Pittsburgh Sleep Quality questionnaire completed by the patients before the procedure and target effect-site propofol concentration recorded at the time of anesthesia induction

Secondary outcome [1]

Total propofol comsuption recorded by a TCI device

Timepoint [1]

At the end of the transvaginal oocyte retrieval

Secondary outcome [2]

Total sedation time recorded by a timer. Sedation begins when the patients lose response to verbal commands and ends when the patient could react to verbal commands.

Timepoint [2]

At the end of the transvaginal oocyte retrieval

Secondary outcome [3]

Post-procedure complication including nausea, vomiting,and pruritus observed by nurse in post anesthesia care unit. A phone interview will be performed after the patient goes home.

Timepoint [3]

within one week after the intervention

Secondary outcome [4]

Emergence time recorded by a timer. Emergence time was defined as the time required for the patient to react to verbal commands after TCI was stopped.

Timepoint [4]

At the end of the transvaginal oocyte retrieval

Eligibility

Key inclusion criteria

Female patients assessed as the American Society of Anesthesiologists (ASA) physical status classification system class I and II who are ready for transvaginal oocyte retrieval

Minimum age

20 Years

Maximum age

45 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

(1) refusal to provide informed consent,
(2) allergy to intravenous propofol, fentanyl, or lidocaine,
(3) hepatic, renal, or neurological dysfunction

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

15/06/2015

Actual

6/07/2015

Date of last participant enrolment

Anticipated

Actual

25/01/2016

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

192

Recruitment outside Australia

Country [1]

Taiwan, Province Of China

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Changhua Christian Hospital, Taiwan (R.O.C.)

Address [1]

135 Nanxiao St. Changhua City, Changhua County 500, Taiwan (R.O.C.)

Country [1]

Taiwan, Province Of China

Primary sponsor type

Hospital

Name

Changhua Christian Hospital, Taiwan (R.O.C.)

Address

135 Nanxiao St. Changhua City, Changhua County 500, Taiwan (R.O.C.)

Country

Taiwan, Province Of China

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ChangHua Christian Hospital Institutional Review Board

Ethics committee address [1]

4F., No.20, Jianbao St., Changhua City, Changhua County 500, Taiwan (R.O.C.)

Ethics committee country [1]

Taiwan, Province Of China

Date submitted for ethics approval [1]

12/03/2015

Approval date [1]

12/05/2015

Ethics approval number [1]

150310

Summary

Brief summary

The majority of oocyte retrievals are currently performed through a transvaginal approach with ultrasonographic guidance. When receiving this procedure, most patients will suffered from painful sensation and move their legs during insertion of transvaginal ultrasound probe and aspiration needle. We anesthesiologists provide proper sedation and analgesics in order to keep patient’s steady position so that obstetricians can perform oocyte retrieval smoothly. Target controlled infusion (TCI) is considered the best way to maintain perioperative sedation since the device enable the drug concentration
in the blood or plasma, or at the effect site, to be controlled continuously.
  According to past animal studies, sleep deprivation potentiated the ability of certain inhalation agent (isoflurane) and intravenous anesthetics (propofol) to produce loss of righting reflex in deprived rats. Besides, recent studies indicated that propofol may induces sedation by increasing firing of GABAergic neurons in the VLPO (ventrolateral preoptic nucleus) which was also known as a key area in non-rapid eye movement (NREM) sleep-promoting pathway. However, the presence of regulatory interactions between anesthesia and sleep was not confirmed currently. 
Thus, we design this study trying to figure out the relationship between sleep quality and target effect-site propofol concentration of TCI during a patient receiving transvaginal oocyte retrieval. Pittsburgh Sleep Quality Index was used to evaluate the patients’ sleep quality and the questionnaire will be completed before the procedure. During oocyte retrieval, Entropy monitoring will be set to assess anesthetic depth and the predicted Ceprop as well as time required for loss of consciouness (loss of response to verbal commands), total sedation time, propofol comsuption, and emergence time will be recorded. After the procedure was completed, the patients were assigned to two groups based on the result of Pittsburgh Sleep Quality Index. Patients with total score less than or equal to 5 was included in the group of good sleep quality and total score greater than 5 was assigned to the group of poor sleep quality. The data collected will be analyzed to decide whether poor sleep quality results in low target effect-site propofol concentration required for adequate sedation during transvaginal oocyte retrieval or not.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Yi-Jer Hsieh

Address

Department of Anesthesiology, Changhua Christian Hospital.
135 Nanxiao St. Changhua City, Changhua County 500, Taiwan (R.O.C.)

Country

Taiwan, Province Of China

Phone

+886 4 723 8595

Fax

161424@cch.org.tw

Contact person for public queries

Name

Chia-Ching Wu

Address

Department of Anesthesiology, Changhua Christian Hospital.
135 Nanxiao St. Changhua City, Changhua County 500, Taiwan (R.O.C.)

Country

Taiwan, Province Of China

Phone

+886 4 723 8595

Fax

161424@cch.org.tw

Contact person for scientific queries

Name

Chia-Ching Wu

Address

Department of Anesthesiology, Changhua Christian Hospital.
135 Nanxiao St. Changhua City, Changhua County 500, Taiwan (R.O.C.)

Country

Taiwan, Province Of China

Phone

+886 4 723 8595

Fax

161424@cch.org.tw

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically