Neostigmine/Glyco-pyrrolate 50 Mikrogram/kg or Sugammadex 2 mg/kg for Reversal of Neuromuscular Blockade in Elderly Patients

NCT ID: NCT06228092

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-04
• Study Completion Date: 2025-05-04

Brief Summary

The aim of this study is to determine the time to TOF ≥ 0.9 after either neostigmine/glycopyrrolate 50 mikrogr/kg or sugammadex 2 mg/kg in patients with age ≥ 75 years. The hypothesis of this study is that sugammadex 2 mg/kg provides a faster time to TOF ≥ 0.9 compared to neostigmine/glycopyrrolate 50 mikrogr/kg.

Detailed Description

Numbers of elderly patients requiring anesthesia and surgery are increasing, and as a group, elderly patients are at high risk of postoperative complications.

Although the use of neuromuscular blocking agents (NMBAs) to improve surgical condition are still debated, they are routinely administered in the clinical setting during anesthesia both to facilitate tracheal intubation and impair the surgical conditions. However, elderly patients administered NMBAs during anesthesia have an increased risk of postoperative residual neuromuscular block which is associated with more frequent episodes of hypoxemia, postoperative pulmonary complications, discomfort and longer hospital length of stay.

To prevent postoperative residual block it is strongly recommended to employ neuromuscular monitoring perioperatively, performed by train-of-four (TOF) stimulation, which enables the anesthetist to titrate the depth of block and to reverse the block if spontaneous recovery has not occurred upon conclusion of surgery.

It is possible to reverse rocuronium induced neuromuscular blockade with either neostigmine/glycopyrrolate (an acetylcholine esterase inhibitor) or sugammadex (a modified cyclodextrin). However, the optimal choice of reversal agent for rocuronium induced neuromuscular blockade in elderly patients is unknown. There is a need for studies investigating which reversal agent is optimal in elderly patients.

This randomized, parallel group trial will compare neostigmine/glycopyrrolate 50 mikrogr/kg or sugammadex 2 mg/kg for reversal of rocuronium induced blockade in elderly patients (≥ 75 years) undergoing robot surgery.

Conditions

Neuromuscular Blockade, Residual

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

neostigmine/glycopyrrolate group

neostigmine/glycopyrrolate 50 mikrogr/kg

Group Type: ACTIVE_COMPARATOR

neostigmine/glycopyrrolate

Intervention Type: DRUG

Anesthesia personnel will administer the drug as a bolus over 5 seconds in an intravenous catheter upon conclusion of anaesthesia with a TOF within the range from TOF count of 2 to a TOF ratio \< 0.60

Sugammadex group

Sugammadex 2 mg/kg

Group Type: ACTIVE_COMPARATOR

Sugammadex

Intervention Type: DRUG

Anesthesia personnel will administer the drug as a bolus over 5 seconds in an intravenous catheter upon conclusion of anaesthesia with a TOF within the range from TOF count of 2 to a TOF ratio \< 0.60

Interventions

neostigmine/glycopyrrolate

Anesthesia personnel will administer the drug as a bolus over 5 seconds in an intravenous catheter upon conclusion of anaesthesia with a TOF within the range from TOF count of 2 to a TOF ratio \< 0.60

Intervention Type: DRUG

Sugammadex

Anesthesia personnel will administer the drug as a bolus over 5 seconds in an intravenous catheter upon conclusion of anaesthesia with a TOF within the range from TOF count of 2 to a TOF ratio \< 0.60

Intervention Type: DRUG

Other Intervention Names

Robinul-Neostigmin; Bridion

Eligibility Criteria

Inclusion Criteria

1. Patients ≥ 75 years old

2. Informed consent

3. Scheduled for robotic assisted laparoscopic surgery under general anesthesia with intubation and use of rocuronium during the entire operation

4. American Society of Anesthesiologists (ASA) physical status classification I to IV

5. Can read and understand Danish

Exclusion Criteria

1. Known allergy to rocuronium, sugammadex or neostigmine/glycopyrrolate

2. Neuromuscular disease that may interfere with neuromuscular data

3. Severe renal impairment defined as eGFR < 30 ml/min

4. Indication for rapid sequence induction

5. Known intestinal or ureter obstruction

6. Known peritonitis

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Matias Vested

OTHER

Sponsor Role: lead

Responsible Party

Matias Vested

MD, Ph.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Matias Vested, MD, PhD

Role: STUDY_CHAIR

Rigshospitalet University of Copenhagen

Locations

Department of anaesthesia, Centre of Head and Orthopedics, Rigshospitalet

Copenhagen, , Denmark

Bispebjerg Hospital

Copenhagen, , Denmark

Department of Pediatric and Obstetric Anaesthesia, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2023-504230-21-00

Identifier Type: -

Identifier Source: org_study_id