Deep Neuromuscular Blockade to Improve Postoperative Quality of Recovery in Ambulatory Gynaecologic Laparoscopy
Overview
- Phase
- Phase 4
- Intervention
- Rocuronium bromide
- Conditions
- Muscle Relaxation
- Sponsor
- Wahba bakhet
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Quality of recovery
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Gynecological laparoscopic surgery is commonly performed as an ambulatory basis for the aim of rapid discharge, reduce hospital stay with reduced costs and to improve postoperative QOR [1,2]. However, the creation of pneumoperitoneum during laparoscopy may cause postoperative pain and other physiological changes [3], which could influence the postoperative QOR negatively [4]. Poor postoperative QOR leads to prolonged hospital stay [5].
Detailed Description
Deep NMB is known to improve surgical conditions and pneumoperitoneium related complications in laparoscopic surgery \[6,7,8,9\]. However, it is unknown whether deep NMB improves postoperative QOR in ambulatory gynecological laparoscopy. Therefore, we designed a double blind randomised trial to compare the effects of deep and moderate NMB on postoperative QOR in ambulatory gynecological laparoscopic surgery. We hypothesized that deep NMB improves postoperative QOR, compared to moderate NMB. The primary outcome was postoperative QOR in POD1. The secondary outcome was quality of surgical conditions, pain scores, time to meet PACU and hospital discharge, and opioid consumption
Investigators
Wahba bakhet
LECTRURE
Ain Shams University
Eligibility Criteria
Inclusion Criteria
- •ASA I and II
Exclusion Criteria
- •Neuromuscular disorders
Arms & Interventions
Moderate block
In the moderate NMB group, a TOF count of 1 to 2 was maintained and NMB was reversed with a combination of neostigmine and glycopyrolate at the end of surgery.
Intervention: Rocuronium bromide
DEEP BLOCK
In the deep NMB-group, a PTC of 1 to 2 twitches was maintained, and NMB was reversed with sugammadex at the end of surgery.
Intervention: Rocuronium
Outcomes
Primary Outcomes
Quality of recovery
Time Frame: 24 hours postoperative
Quality of recovery-40 (QoR-40) questionnaire, which includes five general quality of life dimensions: physical independence (5 items), pain (7 items), .emotional state (9 items), psychological support (7 items), and physical independence (5 items). Each item was graded with a 5-point score: none of the time, some of the time,usually, most of the time and all of the time. The total score on the QoR- 40 questionnaire ranges from 40 to 200 representing, respectively, extremely poor to excellent
Secondary Outcomes
- Postoperative pain(During the length of hospital stay post surgery (on average 24 hours))