The effects of different opioids on emergence from general anesthesia for short gynecological surgery

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN23443592
• Date of registration: 12/01/2016
• Prospective Registration: No
• Primary sponsor: Baskent University Research Fund
• Public title: The effects of different opioids on emergence from general anesthesia for short gynecological surgery
• 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
• Date of first enrolment: 20/04/2015
• Target sample size: 128
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN23443592
• Study type: Interventional
• Study design: Single-centre randomised parallel trial (Treatment)
• Phase: Not Specified

Countries of recruitment

Turkey

Contacts

• Name: Hüseyin Ulas Pinar

Key inclusion & exclusion criteria

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
Exclusion criteria: 1. Psycihiatric disorder
2. Opioid drug abusement

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

General anesthesia in gynecological prcedures
Pregnancy and Childbirth
General anesthesia in gynecological prcedures

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Baskent University Research Fund