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Recovery From dNMB Using Different Sugammadex Doses in Elderly Patients Undergoing Robot-assisted Prostatectomy (RECIR)

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ClinicalTrials.gov Identifier: NCT04854993
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Description
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Brief Summary:
The aim of this prospecive randomized study is to evaluate the effects of a dose of sugammadex increased by 50% compared to a standard dose on recovery time from deep neuromuscular block in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Secondary objectives are to evaluate the different extubation time, time to exit from the operating room (OR), lenght of stay in post-anaesthesia care unit (PACU) and safety (hemodynamic parameters and respiratory function).

Condition or disease Intervention/treatment Phase
Prostate Cancer Neuromuscular Blockade Drug: Sugammadex 6 mg/kg Drug: Sugammadex 4 mg/kg Phase 3

Detailed Description:
An increasing percentage of elderly patients with localized prostate cancer undergo RALP, due to the higher safety and feasibility of this minimally invasive surgical option compared to standard open procedure. This procedure is performed under deep neuromuscular block (dNMB) in order to guarantee an adequate working space. Induction and maintenance of the dNMB require neuromuscular monitoring and adequate reversal at the end of the intervention to prevent postoperative residual curarization (PORC). Sugammadex is the most attractive strategy to titrate reversal according to NMB monitoring data and to ensure a complete recovery of muscle function before extubation. In elderly patients, the risk of PORC and related postoperative complications is higher. For these reasons, we hypothesize that a dose of sugammadex increased by 50% compared to a standard dose could significantly shorten neuromuscular recovery time, extubation time, OR discharge time and PACU length of stay in elderly patients undergoing RALP.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The patient as well as the investigator (care provider) who will administer the different blinded sugammadex dosage and collect postoperative data will be blinded to the group allocation. The randomization and preparation of the drug will be performed by the unblinded staff of hospital experimental pharmacy who will carry out the randomization with a 1: 1 ratio and will assign the different dose to each patient. The drug will be prepared in a shielded pre-filled syringe in order to maintain blindness. In case of emergency, the pharmacy staff will immediately open the randomization code of interest disclosing the group assignment (sugammadex dose).
Primary Purpose: Treatment
Official Title: Recovery From Deep Neuromuscular Blockade Using Different Sugammadex Doses in Elderly Patients Undergoing Laparoscopic Robot-assisted Prostatectomy: a Prospective, Randomized, Double-blind Clinical Trial
Actual Study Start Date : July 13, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Increased dose of sugammadex
A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery
 Drug: Sugammadex 6 mg/kg
i.v. injection of an increased (by 50%) dose of sugammadex to reverse dNMB
Other Name: MK-8616
Active Comparator: Standard dose of sugammadex
A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery
 Drug: Sugammadex 4 mg/kg
i.v. injection of a standard dose of sugammadex to reverse dNMB
Other Name: MK-8616


Outcome Measures
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Primary Outcome Measures :
  1. Neuromuscular recovery time [ Time Frame: 5 minutes ]
    Time from the end of sugammadex administration to train-of-four (TOF)=1


Secondary Outcome Measures :
  1. Time to extubation [ Time Frame: 10 minutes ]
    Time from neuromuscular reversal (TOF=1) to extubation

  2. Time to OR exit [ Time Frame: 30 minutes ]
    Time from neuromuscular reversal (TOF=1) to exit from the operating room

  3. PACU length of stay [ Time Frame: 2 hours ]
    Duration of stay in the post-anaesthesia care unit

  4. Hemodynamic parameters [ Time Frame: up to discharge from post-anaesthesia care unit, an average of 2 hours ]
    Non-invasive blood pressure (mmHg) and heart rate (beats per minute) after sugammadex administration

  5. Respiratory function [ Time Frame: up to discarge from post-anaesthesia care unit, an average of 2 hours ]
    Peripheral oxygen saturation (percentage) and respiratory rate (breaths per minute) after sugammadex administration


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient's age ≥65years
  • prostate cancer
  • robot-assisted laparoscopic radical prostatectomy (RALP)

Exclusion Criteria:

  • inability to obtain written informed consent
  • history of significant liver, renal or pulmonary diseases
  • current smoking
  • chronic or acute alcoholism
  • known or suspected neuromuscular disorders
  • family history of malignant hyperthermia
  • any pre-existing coagulopathy
  • abnormal blood coagulation tests (including prothrombin time <70%; activated partial thromboplastin time >38 seconds and INR >1.20) or preoperative anticoagulant therapies
  • BMI ≥30 Kg/m2
  • known allergy or hypersensitivity to the drugs used in the study
  • planned postoperative admission to intensive care unit.
  • moderate neuromuscular block (TOF 1-3) at the end of surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04854993


Contacts
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Contact: Paola Aceto, MD, PhD +39630154507 paola.aceto@policlinicogemelli.it

Locations
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Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS Recruiting
Rome, Italy, 00168
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
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Principal Investigator: Paola Aceto, MD, PhD Fondazione Policlinico Universitario Agostino Gemelli IRCCS
More Information
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Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT04854993    
Other Study ID Numbers: 3764
2020-004704-34 ( EudraCT Number )
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
sugammadex
elderly
recovery time
robotic surgery
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases