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OpenTrials
Completed

NCT Number: NCT03519633

Role of Curarization During Anesthesia for Laparoscopic Hysterectomy

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.

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Key information

Conditions

Curarization, Postoperative Residual Delayed Emergence from Anesthesia Nausea Neurologic Manifestations PONV Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Postoperative Pain Of Laparoscopic Surgery Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Campus Bio-medico

Roma, RM, 00128, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

Reversal of deep NMB

Neostigmine

Drug

Reversal of moderate NMB

Primary outcomes

  1. Overall pain in the first 24 hrs after gynecologic surgical procedures

    Time frame: First 48 hrs after gynecologic surgical procedures

    0-10 NRS

  2. Recovery time (or Reversal time) from NMB (TOF≥0.9)

    Time frame: 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.

    Recovery time (or Reversal time) from NMB (TOF≥0.9), measured in minutes from to administration of reversal agent to a TOF≥0.9

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
May 9, 2018
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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