Trial Outcomes & Findings for Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy (NCT NCT00527332)

NCT ID: NCT00527332

Last Updated: 2012-01-26

Results Overview

Duration of hospital stay defined as time from start anesthesia to leaving the hospital

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 180 participants
• Primary outcome timeframe: Within 6 months after surgery
• Results posted on: 2012-01-26

Participant Flow

Participant milestones

Measure	Spinal Anesthesia Spinal anesthesia combined with intrathecal morphine	General Anesthesia General anesthesia
Overall Study STARTED	91	89
Overall Study COMPLETED	82	80
Overall Study NOT COMPLETED	9	9

Reasons for withdrawal

Measure	Spinal Anesthesia Spinal anesthesia combined with intrathecal morphine	General Anesthesia General anesthesia
Overall Study Protocol Violation	4	8
Overall Study Withdrew consent	5	1

Baseline Characteristics

Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy

Baseline characteristics by cohort

Measure	Spinal Anesthesia n=91 Participants Spinal anesthesia combined with intrathecal morphine	General Anesthesia n=89 Participants General anesthesia	Total n=180 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	91 Participants n=5 Participants	89 Participants n=7 Participants	180 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	45.9 years STANDARD_DEVIATION 5.5 • n=5 Participants	46.0 years STANDARD_DEVIATION 6.0 • n=7 Participants	45.9 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants	89 Participants n=7 Participants	180 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Sweden	91 participants n=5 Participants	89 participants n=7 Participants	180 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 6 months after surgery

Population: Participants who completed the study were analyzed

Duration of hospital stay defined as time from start anesthesia to leaving the hospital

Outcome measures

Measure	Spinal Anesthesia n=82 Participants Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol.	General Anesthesia n=80 Participants General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
Duration of Hospital Stay.	46 Hours Interval 22.0 to 125.0	50 Hours Interval 24.0 to 100.0

SECONDARY outcome

Timeframe: Within 6 months after the surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 6 months after surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 6 months after the surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 6 months after the surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 6 months after the surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 6 months after the surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 6 months after the surgery

Outcome measures

Outcome data not reported

Adverse Events

Spinal Anesthesia

Serious events: 7 serious events

Other events: 17 other events

Deaths: 0 deaths

General Anesthesia

Serious events: 10 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Spinal Anesthesia n=91 participants at risk Spinal anesthesia combined with intrathecal morphine	General Anesthesia n=89 participants at risk General anesthesia
Injury, poisoning and procedural complications Urinary bladder injury	2.2% 2/91 • Number of events 2	1.1% 1/89 • Number of events 1
Infections and infestations Infections	7.7% 7/91 • Number of events 7	10.1% 9/89 • Number of events 9

Other adverse events

Measure	Spinal Anesthesia n=91 participants at risk Spinal anesthesia combined with intrathecal morphine	General Anesthesia n=89 participants at risk General anesthesia
General disorders Abdominal wound complication	13.2% 12/91 • Number of events 12	11.2% 10/89 • Number of events 10
Renal and urinary disorders Lower urinary tract infection	5.5% 5/91 • Number of events 5	6.7% 6/89 • Number of events 6

Additional Information

Dr Preben Kjolhede

Deptartment of Obstetrics and Gynecology, University Hospital, Linköping, Sweden

Phone: +46101030000

Email: Preben.Kjolhede@lio.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place