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

Matias Vested

Status and phase: Enrolling; Phase 4

Conditions: Neuromuscular Blockade, Residual

Treatments: Drug: neostigmine/glycopyrrolate; Drug: Sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT06228092

2023-504230-21-00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

neostigmine/glycopyrrolate group

Active Comparator group

Description:

neostigmine/glycopyrrolate 50 mikrogr/kg

Treatment:

Drug: neostigmine/glycopyrrolate

Sugammadex group

Active Comparator group

Description:

Sugammadex 2 mg/kg

Treatment:

Drug: Sugammadex