Phase 4 Completed N=79 Randomized Single-blind Treatment

Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery

cholecystitis · Endometriosis · Bowel Obstruction · Fibroids

Source: ClinicalTrials.gov NCT02812186 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2020

Primary outcomePrimary: Peak Airway Pressures — 25.5; 28.3; 28; 30 cm H2O — p=0.01

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

This is a two period cross-over study randomizing patients undergoing laparoscopic surgery into 2 different groups: group 1 in which patients receive "deep neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "moderate blockade" and, group 2 in which patients receive "moderate neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "deep blockade". The deep neuromuscular block is defined as post tetanic count of 1 to 2 and the moderate neuromuscular block is defined as 1-2 twitches. In all patients, sugammadex is used to reverse the block at the end of surgery in order to obtain optimal extubating conditions.

Outcome Measures

Outcome	Result	p-value
PRIMARY Peak Airway Pressures	25.5; 28.3; 28; 30	0.01 sig
SECONDARY Abdominal Insufflation Pressure	15; 15	0.28
SECONDARY Surgical Rating Scale	5; 5	0.63

Eligibility Criteria

Inclusion Criteria

Each participant must be willing and able to provide written informed consent for the study.
Each participant must be American Society of Anesthesiologists (ASA) class I, II or III.
Each participant must be scheduled for elective laparoscopic surgery (this includes robotic laparoscopic surgery).
Expected surgical duration of 60 min or longer

Exclusion Criteria

Inability to give informed oral or written consent
Known or suspected neuromuscular disorders impairing neuromuscular function;
True allergies as defined as hypotension, bronchospasm, or anaphylaxis to muscle relaxants, anesthetics or opioids
A history (patient or family) of malignant hyperthermia
A contraindication for neostigmine administration
Renal insufficiency, as defined by serum creatinine levels at 2.5 fold the normal level
Body mass index >40 kg/m^2
Significant respiratory disease.
Planned postoperative mechanical ventilation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02812186). 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. Informational only — not medical advice.