Clinical trial NCT06228092: Neostigmine/Glyco-pyrrolate 50 Mikrogram/kg or Sugammadex 2 mg/kg for Reversal of Neuromuscular Blockade in Elderly Patients
Official title: A Blinded Randomized Study of Neostigmine/Glyco-pyrrolate 50 Mikrogram/kg or Sugammadex 2 mg/kg for Reversal of Neuromuscular Blockade in Elderly Patients (≥ 75 Years)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Neuromuscular Blockade, Residual
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to TOF > 0.9
timeFrame: first TOF ratio ≥ 0.9 (time until complete recovery from effect of muscle relaxant) followed by a stable signal with a TOF ratio ≥ 0.9 for at least two minutes.
Secondary outcomes:
measure: Residual muscular blockade
timeFrame: Assessed upon arrival at PACU, after 20 minutes at PACU and after 90 minutes at PACU
Other outcomes:
measure: Episodes of desaturation
timeFrame: During the period of the PACU stay
measure: New cardiac arrythmias
timeFrame: Within 180 minutes after administration of reversal agent
measure: Airway obstruction
timeFrame: During the period of the PACU stay
measure: Reintubation
timeFrame: During the period of the PACU stay
Locations:
city: Copenhagen
country: Denmark
facility: Department of anaesthesia, Centre of Head and Orthopedics, Rigshospitalet
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Copenhagen
country: Denmark
facility: Department of Pediatric and Obstetric Anaesthesia, Rigshospitalet
Study officials:
affiliation: Rigshospitalet University of Copenhagen
name: Matias Vested, MD, PhD
role: STUDY_CHAIR
References: