Deep NMB in Ambulatory Gynecological Laparoscopy

Wahba bakhet

Status and phase: Completed; Phase 4

Conditions: Muscle Relaxation

Treatments: Drug: Rocuronium bromide; Drug: Rocuronium

Study type: Interventional

Funder types: Other

Identifiers

NCT04105764

elite NMB

Details and patient eligibility

About

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].

Full 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

Enrollment: 80 patients

Sex: Female

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA I and II

Exclusion criteria

• Neuromuscular disorders

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

DEEP BLOCK

Active Comparator group

Description:

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.

Treatment:

Drug: Rocuronium

Moderate block

Active Comparator group

Description:

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.

Treatment:

Drug: Rocuronium bromide