Role of Curarization During Anesthesia for Gynecologic Surgical Laparoscopic Procedures

Curarization, Postoperative Residual Clinical Trial

Official title:

The Role of Curarization During Anesthesia for Gynecologic Surgical Laparoscopic Procedures: a Double Blind Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03519633
• Other study ID #: GYN LPS-CUR 2018
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 30, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: July 2018
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 30, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Curarization, Postoperative Residual
• Delayed Emergence from Anesthesia

Intervention

Drug:
• Sugammadex
Reversal of deep NMB
• Neostigmine
Reversal of moderate NMB

Locations

Country	Name	City	State
Italy	Campus Bio-medico	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall pain in the first 48 hrs after gynecologic surgical procedures	0-10 NRS	First 48 hrs after gynecologic surgical procedures
Primary	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.