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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] 286388 0
Nil
Universal Trial Number (UTN)
U1111-1168-5080
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep quality 294532 0
Propofol required during Transvaginal Oocyte Retrieval 294533 0
Condition category
Condition code
Anaesthesiology 294841 294841 0 0
Anaesthetics
Reproductive Health and Childbirth 295203 295203 0 0
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] 291456 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295052 0
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] 295052 0
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] 313702 0
Total propofol comsuption recorded by a TCI device
Timepoint [1] 313702 0
At the end of the transvaginal oocyte retrieval
Secondary outcome [2] 313703 0
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] 313703 0
At the end of the transvaginal oocyte retrieval
Secondary outcome [3] 313704 0
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] 313704 0
within one week after the intervention
Secondary outcome [4] 314674 0
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] 314674 0
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?
No
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] 6766 0
Taiwan, Province Of China
State/province [1] 6766 0

Funding & Sponsors
Funding source category [1] 290960 0
Hospital
Name [1] 290960 0
Changhua Christian Hospital, Taiwan (R.O.C.)
Country [1] 290960 0
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] 289642 0
None
Name [1] 289642 0
Address [1] 289642 0
Country [1] 289642 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292558 0
ChangHua Christian Hospital Institutional Review Board
Ethics committee address [1] 292558 0
4F., No.20, Jianbao St., Changhua City, Changhua County 500, Taiwan (R.O.C.)
Ethics committee country [1] 292558 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 292558 0
12/03/2015
Approval date [1] 292558 0
12/05/2015
Ethics approval number [1] 292558 0
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 55926 0
Dr Yi-Jer Hsieh
Address 55926 0
Department of Anesthesiology, Changhua Christian Hospital.
135 Nanxiao St. Changhua City, Changhua County 500, Taiwan (R.O.C.)
Country 55926 0
Taiwan, Province Of China
Phone 55926 0
+886 4 723 8595
Fax 55926 0
Email 55926 0
[email protected]
Contact person for public queries
Name 55927 0
Chia-Ching Wu
Address 55927 0
Department of Anesthesiology, Changhua Christian Hospital.
135 Nanxiao St. Changhua City, Changhua County 500, Taiwan (R.O.C.)
Country 55927 0
Taiwan, Province Of China
Phone 55927 0
+886 4 723 8595
Fax 55927 0
Email 55927 0
[email protected]
Contact person for scientific queries
Name 55928 0
Chia-Ching Wu
Address 55928 0
Department of Anesthesiology, Changhua Christian Hospital.
135 Nanxiao St. Changhua City, Changhua County 500, Taiwan (R.O.C.)
Country 55928 0
Taiwan, Province Of China
Phone 55928 0
+886 4 723 8595
Fax 55928 0
Email 55928 0
[email protected]

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