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Trial registered on ANZCTR


Registration number
ACTRN12617000098336
Ethics application status
Approved
Date submitted
2/12/2016
Date registered
17/01/2017
Date last updated
17/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A suitable sedative dose of remifentanil for both mother and fetus in fetoscopic surgery
Scientific title
Suitable sedative dose of remifentanil in women undergoing fetoscopic laser photocoagulation for twin-twin transfusion syndrome
Secondary ID [1] 288868 0
None
Universal Trial Number (UTN)
U1111-1190-5506
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregant with twin-twin transfusion syndrome(TTTS) 298159 0
Condition category
Condition code
Anaesthesiology 300961 300961 0 0
Anaesthetics
Reproductive Health and Childbirth 300962 300962 0 0
Fetal medicine and complications of pregnancy
Surgery 300963 300963 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
According to different rates of remifentanil administration, R1, R2 and R3 group are administered different dose rate of remifentanil (0.05micro-g/kg/min and 0.08micro-g/kg/min). Anesthesia induction of CSEA was done 5min before remifentanil administration. Intravenous remifentanil was administrated before operation and stopped after laser photocoagulation. Dose administered and logged by anaesthetist.
Intervention code [1] 296553 0
Treatment: Drugs
Comparator / control treatment
remifentanil administrative dose rate of 0.02micro-g/kg/min as comparator state
Control group
Dose comparison

Outcomes
Primary outcome [1] 300387 0
mean arterial pressure (MAP) by digital sphygmomanometer
Timepoint [1] 300387 0
Before induction of anesthesia (T0), 5 min after CSEA (T1), the time when fetal immobilization after remifentanil administration (T2), incision (T3), and laser coagulation (T4)
Primary outcome [2] 300388 0
oxygen saturation (SpO2) by pulse oximeter
Timepoint [2] 300388 0
Before induction of anesthesia (T0), 5 min after CSEA (T1), the time when fetal immobilization after remifentanil administration (T2), incision (T3), and laser coagulation (T4)
Primary outcome [3] 300389 0
Fetal movement by ultrasound
Timepoint [3] 300389 0
Before induction of anesthesia (T0), 5 min after CSEA (T1), the time when fetal immobilization after remifentanil administration (T2), incision (T3), and laser coagulation (T4)
Secondary outcome [1] 329862 0
fetal movement recovering time by ultrasound
Timepoint [1] 329862 0
from the timepoint of stopping administered drugs to fetal movement
Secondary outcome [2] 330331 0
Kreb's score for fetal heart rate by ultrasoud
Timepoint [2] 330331 0
Before induction of anesthesia (T0), 5 min after CSEA (T1), the time when fetal immobilization after remifentanil administration (T2), incision (T3), and laser coagulation (T4)
Secondary outcome [3] 330332 0
Respiratory rate (RR) of mother by digit respiratory monitor
Timepoint [3] 330332 0
Before induction of anesthesia (T0), 5 min after CSEA (T1), the time when fetal immobilization after remifentanil administration (T2), incision (T3), and laser coagulation (T4)
Secondary outcome [4] 330333 0
Heart rate of mother by digit electrocardiogram
Timepoint [4] 330333 0
Before induction of anesthesia (T0), 5 min after CSEA (T1), the time when fetal immobilization after remifentanil administration (T2), incision (T3), and laser coagulation (T4)
Secondary outcome [5] 330334 0
Anxiety of mother by visual analog test (AVAT) by test standard
Timepoint [5] 330334 0
Before induction of anesthesia (T0), 5 min after CSEA (T1), the time when fetal immobilization after remifentanil administration (T2), incision (T3), and laser coagulation (T4)
Secondary outcome [6] 330335 0
Maternal arterial oxygen partial pressure (PaO2) by blood gas analysis
Timepoint [6] 330335 0
Before induction of anesthesia (T0) and laser coagulation (T4)
Secondary outcome [7] 330336 0
Maternal arterial carbon dioxide partial pressure (PaCO2) by blood gas analysis
Timepoint [7] 330336 0
Before induction of anesthesia (T0) and laser coagulation (T4)

Eligibility
Key inclusion criteria
Thirty patients with TTTS pregnancies (18-26 weeks’ gestation, maternal age 19-35 years) undergoing elective fetoscopic laser photocoagulation were included in this study. All patients were American Society of Anesthesiologists (ASA) physical status I-II
Minimum age
19 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
with cardiopulmonary comorbid conditions and emergent indications for intervention (e.g. fetal asphyxia, abruptio placenta, umbilical cord prolapse).

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
SPSS version 11.0 software was used for statistical analysis. The paired t-test and analysis of variance were performed for intragroup and intergroup measurement data. The chi-squared test was used to compare numeric data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
Actual
28/10/2016
Date of last data collection
Anticipated
28/04/2017
Actual
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 8428 0
China
State/province [1] 8428 0
Liaoning

Funding & Sponsors
Funding source category [1] 295101 0
Hospital
Name [1] 295101 0
Department of anesthesiology, Shengjing hospital, China medical university
Country [1] 295101 0
China
Primary sponsor type
Hospital
Name
Department of anesthesiology, Shengjing hospital, China medical university
Address
NO. 36, Sanhao street, Heping district, Shenyang, 110003
Country
China
Secondary sponsor category [1] 293919 0
Hospital
Name [1] 293919 0
Department of obstetric, Shengjing hospital, China medical university
Address [1] 293919 0
NO. 36, Sanhao Street, Heping District, Shenyang, 110003
Country [1] 293919 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296457 0
Ethics committee of Shengjing Hospital of China Medical University
Ethics committee address [1] 296457 0
NO. 36, Sanhao Street, Heping district, Shenyang, 110003
Ethics committee country [1] 296457 0
China
Date submitted for ethics approval [1] 296457 0
12/08/2015
Approval date [1] 296457 0
16/03/2016
Ethics approval number [1] 296457 0
2016PS29J

Summary
Brief summary
We observed the impact of different intravenous pumping rates of remifentanil on the mother and fetus under combined spinal epidural anesthesia (CSEA) in fetoscopic surgery. Thirty patients with twin-twin transfusion syndrome (TTTS) pregnancies undergoing fetoscopic laser photocoagulation were randomized into three groups (R1, R2 and R3, ten cases per group, 0.02micro-g/kg/min, 0.05micro-g/kg/min and 0.08micro-g/kg/min), according to different rates of remifentanil administration. Anesthesia induction of CSEA was done 5min before remifentanil administration. Intravenous remifentanil was administrated before operation and stopped after laser photocoagulation. During the period, we monitored fetal movement through ultrasonic test. Operation started when fetal immobilization. We recorded the time of fetal immobilization and fetal movement recovering. Fetal movement and Kreb's score for fetal heart rate were simultaneously recorded. Maternal changes in oxygen saturation (SpO2), respiratory rate (RR), mean arterial pressure (MAP), heart rate (HR), and anxiety visual analog test (AVAT)were recorded at the following time points, before induction of anesthesia (T0), 5 min after CSEA (T1), the time when fetal immobilization after remifentanil administration (T2), incision (T3), and laser coagulation (T4). Maternal arterial oxygen partial pressure(PaO2) and arterial carbon dioxide partial pressure(PaCO2) were measured on T0 and T4.
Maternal cardiopulmonary function remained stable after remifentanil administration. PaCO2 showed no significant difference in three groups on T0 and T4(P>0.05). SpO2, RR, MAP, HR, PaO2, AVAT values and Kreb's scores were decreased in turn from R1 to R3 group (p<0.05). There were two cases of fetal movements during laser photocoagulation in R1 groups, but none in R2 and R3 groups. The time for fetal immobilization fetal movement recovering were shorten in turn from R1 to R3 group (p<0.05).
In fetoscopic surgery for TTTS, CSEA combined with a suitable dose of remifentanil can improve the maternal and fetal sedative effects without adverse effects. We propose that the appropriate rate of remifentanil dose in combination with CSEA during TTTS surgery is 0.05micro-g/kg/min.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1279 1279 0 0
/AnzctrAttachments/370414-Ethics approval.pdf (Ethics approval)
Attachments [2] 1282 1282 0 0
/AnzctrAttachments/370414(v02-12-2016-00-46-57)-Participant consent.pdf (Participant information/consent)

Contacts
Principal investigator
Name 64714 0
Prof Ping Zhao
Address 64714 0
NO.36, Sanhao street, Heping district, Shenyang,110003
Department of anesthesiology, Shengjing hospital of China medical university
Country 64714 0
China
Phone 64714 0
+86-024-25672468
Fax 64714 0
Email 64714 0
[email protected]
Contact person for public queries
Name 64715 0
Guang Han
Address 64715 0
NO.36, Sanhao street, Heping district, Shenyang,110003
Department of anesthesiology, Shengjing hospital of China medical university
Country 64715 0
China
Phone 64715 0
+86-18940258839
Fax 64715 0
Email 64715 0
[email protected]
Contact person for scientific queries
Name 64716 0
Guang Han
Address 64716 0
NO.36, Sanhao street, Heping district, Shenyang,110003
Department of anesthesiology, Shengjing hospital of China medical university
Country 64716 0
China
Phone 64716 0
+86-18940258839
Fax 64716 0
Email 64716 0
[email protected]

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