Role of Curarization During Anesthesia for Gynecologic Surgical Laparotomy Procedures

NCT03519724 | Unknown Phase 2

• 1 other identifier: GYN LPTM-CUR 2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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 gynecologic surgery, 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

Conditions

Curarization, Postoperative Residual

Outcome Measures

Primary Outcomes (2)

• Overall pain in the first 48 hrs after gynecologic surgical procedures

  0 - 10 NRS scale of the overall pain in the first 48 hrs after gynecologic surgical procedures

  First 48 hrs after gynecologic surgical procedures

• Recovery time (or Reversal time) from NMB (TOF≥0.9)

  The recovery time (or Reversal time) will be measured in minutes from the administration of reversal agent to a TOF≥0.9

  The recovery time (or Reversal time) will be measured in minutes after the administration of reversal agent at the end of the surgical procedure

Study Arms (2)

SUG

EXPERIMENTAL

Drug: Sugammadex

NEO

ACTIVE COMPARATOR

Drug: Neostigmine

Interventions

Sugammadex DRUG

Reversal of deep NMB

SUG

Neostigmine DRUG

Reversal of moderate NMB

NEO

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Campus Bio-medico

Roma, RM, 00128, Italy

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: May 9, 2018
• Study Start: July 30, 2018
• Primary Completion: September 30, 2018
• Study Completion: January 30, 2019
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)