Role of Curarization During Anesthesia for Laparoscopic Hysterectomy

The Role of Deep Neuromuscular Blockade and Sugammadex in Laparoscopic Hysterectomy: A Randomized Controlled Trial

The primary outcome of this study is to investigate whether deep NMB reversed with Sugammadex is superior to moderate NMB reversed with Neostigmine, in terms of overall pain in the first 48 hrs after laparoscopic hysterectomy, reversal time from NMB (TOF≥0.9) and direct and indirect costs. Additionally we will also assess: drugs consumption for pain and antiemetics (rescue dose), surgical conditions, hemodynamic and respiratory stability, operation time, anesthesia time, total amount and flow rate of CO2, insufflation time, resolution of post-operative ileus, dry mouth and PONV in the first 48 hours, patient satisfaction.

Study Overview

• Status: Completed
• Conditions: PONV; Postoperative Pain Of Laparoscopic Surgery; Curarization, Postoperative Residual
• Intervention / Treatment: Drug: Sugammadex; Drug: Neostigmine

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00128
      • Campus Bio-Medico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age 18-75 years BMI between 16 and 40 Kg/m2 ECOG Performance Status tra 0 e 1 American Society Anesthesiologist (ASA) class 1 or 3 Able to provide informed consent to trial procedures

Exclusion Criteria:

• Age < 18 or > 75 years
• BMI <16 o > 40 Kg/m2
• ECOG Performance Status >1
• Pregnancy
• Active or recent pelvic inflammation
• Anticipated airway difficulty
• Patients with history of allergy to rocuronium, neostigmine or sugammadex
• Allergy to NSAIDs
• Previous opioids consumption for chronic pain
• Patients receiving drugs for different medical conditions, that may prolong or shorten the duration of rocuronium effect (e.g aminoglycosides, magnesium)
• Hepatic or renal failure
• Persistent coagulopathy
• Neurological or cognitive disorders
• Conversion from laparoscopic to open surgery Onset of intraoperative complications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SUG	Drug: Sugammadex; Reversal of deep NMB
Active Comparator: NEO	Drug: Neostigmine; Reversal of moderate NMB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time (or Reversal time) from NMB (TOF≥0.9)	Recovery time (or Reversal time) from NMB (TOF≥0.9), measured in minutes from to administration of reversal agent to a TOF≥0.9	Recovery time (or Reversal time) from NMB (TOF≥0.9) will be measured after the administration of reversal agent at the end of the surgical procedure.
Overall pain in the first 24 hrs after gynecologic surgical procedures	0-10 NRS	First 48 hrs after gynecologic surgical procedures

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (Actual): May 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: postoperative pain; sugammadex; deep neuromuscular blockade; laparoscopic hysterectomy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Delayed Emergence from Anesthesia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Neurotransmitter Agents; Cholinergic Agents; Parasympathomimetics; Cholinesterase Inhibitors; Neostigmine
• Other Study ID Numbers: GYN LPS-CUR 2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No