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Completed

NCT Number: NCT04854993

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

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).

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Key information

Age range

65 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex 6 mg/kg

Drug

i.v. injection of an increased (by 50%) dose of sugammadex to reverse dNMB

Other names: MK-8616

Sugammadex 4 mg/kg

Drug

i.v. injection of a standard dose of sugammadex to reverse dNMB

Other names: MK-8616

Primary outcomes

  1. Neuromuscular recovery time

    Time frame: 5 minutes

    Time from the end of sugammadex administration to train-of-four (TOF)=1

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study 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

Acronym: RECIR

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2021
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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