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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list