Back to resultsRole of Curarization During Anesthesia for Gynecologic Surgical Laparoscopic Procedures
Primary Purpose
Curarization, Postoperative Residual
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Sugammadex
Neostigmine
Sponsored by
About this trial
This is an interventional prevention trial for Curarization, Postoperative Residual
Eligibility Criteria
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
Sites / Locations
- Campus Bio-medico
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SUG
NEO
Arm Description
Outcomes
Primary Outcome Measures
Overall pain in the first 48 hrs after gynecologic surgical procedures
0-10 NRS
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03519633
First Posted
March 9, 2018
Last Updated
July 9, 2018
Sponsor
Campus Bio-Medico University
1. Study Identification
Unique Protocol Identification Number
NCT03519633
Brief Title
Role of Curarization During Anesthesia for Gynecologic Surgical Laparoscopic Procedures
Official Title
The Role of Curarization During Anesthesia for Gynecologic Surgical Laparoscopic Procedures: a Double Blind Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2018 (Anticipated)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
January 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Curarization, Postoperative Residual
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SUG
Arm Type
Experimental
Arm Title
NEO
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
Reversal of deep NMB
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Intervention Description
Reversal of moderate NMB
Primary Outcome Measure Information:
Title
Overall pain in the first 48 hrs after gynecologic surgical procedures
Description
0-10 NRS
Time Frame
First 48 hrs after gynecologic surgical procedures
Title
Recovery time (or Reversal time) from NMB (TOF≥0.9)
Description
Recovery time (or Reversal time) from NMB (TOF≥0.9), measured in minutes from to administration of reversal agent to a 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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Campus Bio-medico
City
Roma
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corrado Terranova
Phone
06225411203
Ext
+39
Email
c.terranova@unicampus.it
12. IPD Sharing Statement
Plan to Share IPD
No
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Role of Curarization During Anesthesia for Gynecologic Surgical Laparoscopic Procedures
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