CompletedPhase 2

Role of Curarization During Anesthesia for Laparoscopic Hysterectomy

Italy238 participantsStarted 2018-04-01

Plain-language 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 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.

Who can participate

Age range18 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Overall pain in the first 24 hrs after gynecologic surgical procedures

Timeframe: First 48 hrs after gynecologic surgical procedures

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

Timeframe: 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.

Trial details

NCT IDNCT03519633

SponsorCampus Bio-Medico University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

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