Condition category
Pregnancy and Childbirth
Date applied
11/01/2016
Date assigned
12/01/2016
Last edited
12/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dilatation and Curettage (a procedure where tissue is removed from the womb to diagnose or treat certain conditions) and endometrial biopsies (a procedure where a small sample is taken from the lining of the womb to be looked at under a microscope) are increasingly common gynecological (women’s reproductive health) procedures. These procedures are usually carried out under a general anesthetic (drugs used to put patients to sleep). It has been found that the type of anesthetic drug used can have an effect on how long it takes for the patient to recover enough to leave the hospital. Two commonly used drugs are fentanyl and remifentanil, which act by causing drowsiness and preventing pain messages from reaching the brain. The aim of this study is to find out whether there is a difference between emergence times (time for the patient to wake up) between the two drugs, and find out which is preferable to patients.

Who can participate?
Adult women who have had minor gynecological surgery (i.e. to take samples from inside the womb).

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in both groups are sedated using propofol and midazolam (standard practice). Those in the first group are also given remifentanil at a dose of 1 microgram per kg of weight to sedate them before their procedure. Those in the second group are also given fentanyl at the same dose to sedate them before their procedure. For both groups, if it is necessary to deepen the level of sedation, additional doses of 0.2 microgram per kg of weight can be added. After the surgery, the time until they wake up from their anesthesia is measured in the post-anesthesia care unit, and the time taken until they can be discharged from the post-anesthesia care unit.

What are the possible benefits and risks of participating?
There are no direct benefits or risks to patients taking part in this study, as the anesthetic techniques involved are used in general practice.

Where is the study run from?
Baskent University Konya Research Centre (Turkey)

When is the study starting and how long is it expected to run for?
March 2015 to February 2016

Who is funding the study?
Baskent University Research Fund (Turkey)

Who is the main contact?
Mr Hüseyin Ulaş Pınar
huseyinpinar2002@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Hüseyin Ulaş Pınar

ORCID ID

Contact details

Baskent University Konya Research Center
Hocacihan Mah. Saray cad No: 1
Konya
42080
Turkey
+90 332 257 0606
huseyinpinar2002@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effects of remifentanil or fentanyl administration on emergence from general anesthesia with mask after dilatation and curettage or endometrial biopsy procedures in ASA I-II patients

Acronym

Study hypothesis

Remfentanil provides earlier emergence from general anesthesia when compared with fentanil administration for general anesthesia for short gynecological procedures.

Ethics approval

Baskent University Institutional Review Board and Ethics Committee, 01/04/2015, ref: KA 15/93

Study design

Single-centre randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

General anesthesia in gynecological prcedures

Intervention

Participants are randomly allocated to one of two groups by computer.

Group 1: Patients are given 0.02 mg/kg midazolam (Dormicum) IV, in addition to IV 1 mcg/kg remifentanil (Ultiva) administered over thirty seconds. Participants are then given 2 mg/kg propofol (Pofol) for anesthesia induction. Additional dosing can be given if required according to the bispectral index guidance (0.3 mg / kg propofol and 0.2 mcg /kg Remifentanil) during the procedure.

Group 2: Patients are given 0.02 mg/kg midazolam (Dormicum) IV, in addition to IV 1 mcg/kg fentanyl (Fentanyl) administered over thirty seconds. Participants are then given 2 mg/kg propofol (Pofol) for anesthesia induction. Additional dosing can be given if required according to the bispectral index guidance (0.3 mg / kg propofol and 0.2 mcg /kg fentanyl) during the procedure.

Participants in both groups are then observed in the post-anesthesia care unit in order to determine emergence time from general anesthesia.

Intervention type

Drug

Phase

Not Specified

Drug names

1. Remifentanil
2. Fentanyl

Primary outcome measures

1. Emergence time from general anesthesia is determined by recording time taken for the patient to open their eyes and provide a verbal answer to a question
2. Discharge time from post-anesthesia care unit is determined according to modified Aldrete score at the time of discharge from the post-anesthesia care unit

Secondary outcome measures

1. Pain is measured using the visual analog scale post-operatively in the post-anesthesia care unit
2. Additional analgesic requirement (if VAS is upper 5 point) post-operatively in the post-anesthesia care unit
3. Patient satisfaction with anesthesia is measured using the visual analogue scale post-operatively in the post-anesthesia care unit
4. Intra-operative dreaming is measured through patient interviews 10 minutes post-operatively

Overall trial start date

20/03/2015

Overall trial end date

20/02/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female patients between 18 and 60 years
2. ASA physical status I-II
3. Have undergone dilatation curettage and/or endometrial biopsy procedures

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

128

Participant exclusion criteria

1. Psycihiatric disorder
2. Opioid drug abusement

Recruitment start date

20/04/2015

Recruitment end date

20/01/2016

Locations

Countries of recruitment

Turkey

Trial participating centre

Baskent University Konya Research Centre
Baskent University Hospital Group Hoca Cihan Mahallesi Saray Cad. 1
Konya
42080
Turkey

Sponsor information

Organisation

Baskent University Research Fund

Sponsor details

Bağlıca Kampüsü Eskişehir Yolu 20. km
Bağlıca
06810
Turkey
+90312 2466679
tip@baskent.edu.tr

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Baskent University Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish results in a peer reviewed journal.

Intention to publish date

31/05/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/04/2016: An additional secondary outcome measure has been added (Intra-operative dreaming).