Phase 4 N=14 Randomized Triple-blind Treatment

Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade

Neuromuscular Blockade

Bottom Line

View on ClinicalTrials.gov: NCT01933425 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2015

Primary outcome: Primary: Intraabdominal Distance (Centimeters) — 9.3; 9.0 centimeters — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: rocuronium (Drug); sugammadex (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Herlev Hospital
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Intraabdominal Distance (Centimeters)	8.6; 8.2	<0.05 sig
SECONDARY Intraabdominal Distance (Centimeters)	8.6; 8.2	<0.05 sig
SECONDARY Surgical Conditions During Suturing of the Abdominal Fascia	7; 2; 0; 5; 0; 0	—

Summary

To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with pneumoperitoneum 12 mmHg. Hypothesis: Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to skin surface, cm) compared to no neuromuscular blockade.

Eligibility Criteria

Inclusion Criteria

patients > 18 years old
elective laparoscopic operation
can read and understand Danish
informed consent

Exclusion Criteria

BMI > 30 kg/cm2
known allergy to medications that are included in the project,
severe renal disease, defined by S-creatinine> 0,200 mmol/L, GFR 12 mmHg on the insufflator

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01933425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.