Trial Outcomes & Findings for Evaluation of Pharmacogenetic Factors Affecting Fentanyl Requirements for Postoperative Pain Control (NCT NCT00824772)

Results Overview

Recruitment status

COMPLETED

Target enrollment

204 participants

Primary outcome timeframe

24 hr after surgery

Results posted on

2013-06-04

* Dates of recruitment: 2008 Sep - 2010 Feb * Type of location: university hospital

No group assignment required for this study.

Participant milestones
Measure	Gynecologic Patients Undergoing TAH, LAVH * Inclusion criteria: 19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia * Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity
Overall Study STARTED	204
Overall Study COMPLETED	196
Overall Study NOT COMPLETED	8

Reasons for withdrawal
Measure	Gynecologic Patients Undergoing TAH, LAVH * Inclusion criteria: 19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia * Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity
Overall Study Withdrawal by Subject	8

Evaluation of Pharmacogenetic Factors Affecting Fentanyl Requirements for Postoperative Pain Control

Baseline characteristics by cohort
Measure	Gynecologic Patients Undergoing TAH, LAVH n=204 Participants * Inclusion criteria: 19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia * Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	204 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	45.3 years STANDARD_DEVIATION 4.9 • n=99 Participants
Sex: Female, Male Female	204 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment Korea, Republic of	204 participants n=99 Participants

Timeframe: 24 hr after surgery

Outcome measures
Measure	Gynecologic Patients Undergoing TAH, LAVH n=196 Participants * Inclusion criteria: 19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia * Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity
Postoperative Cumulative Fentanyl Consumption	836 mcg Standard Deviation 416

Timeframe: 48hr after surgery

Outcome measures
Measure	Gynecologic Patients Undergoing TAH, LAVH n=196 Participants * Inclusion criteria: 19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia * Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity
Postoperative Cumulative Fentanyl Consumption	1028 mcg Standard Deviation 520

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Inje University

Phone: 82-2-950-1168