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

Neuromuscular Blockade, Residual Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06228092
• Other study ID #: 2023-504230-21-00
• Status: Recruiting
• Phase: Phase 4
• Start date: December 4, 2023
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: Rigshospitalet, Denmark
• Contact: Matias Vested, MD, PhD
• Phone: +4535457547
• Email: matias.vested[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Neuromuscular Blockade, Residual

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Department of anaesthesia, Centre of Head and Orthopedics, Rigshospitalet	Copenhagen
Denmark	Department of Pediatric and Obstetric Anaesthesia, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Matias Vested

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Episodes of desaturation	Occurrence of episodes of desaturation defined as more than 3 minutes with spO2 < 88%.	During the period of the PACU stay
Other	New cardiac arrythmias	Occurrence of new cardiac arrythmias (bradycardia or tachycardia defined as atrial fibrillation, atrial flutter, sinus tachycardia (>95 bpm), sinus bradycardia (<45 bpm))	Within 180 minutes after administration of reversal agent
Other	Airway obstruction	Occurrence of upper airway obstruction	During the period of the PACU stay
Other	Reintubation	Occurrence of reintubation	During the period of the PACU stay
Primary	Time to TOF > 0.9	time to TOF = 0.9 after administration of either sugammadex or neostigmine/glycopyrrolate	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	Residual muscular blockade	Sign of residual muscular blockade defined as a composite (assessed upon arrival at PACU) of either: hand grip strength for 5 seconds; occurrence of double vision/blurred vision (yes/no); ability to track objects with eyes (follow finger of examiner) (yes/no); ability to sustain head lift for 5 seconds (yes/no); ability to protrude the tongue for 5 seconds (yes/no); tongue depressor test (prevent removal of a wooden tongue depressor from between the incisor teeth (yes/no); ability to open the eyes for 5 seconds (yes/no); ability to smile (yes/no); ability to speak (yes/no); occurrence of dysphagia/ swallowing impairment (ability to drink 20 ml of water) (yes/no); occurrence of upper airway obstruction; subjective symptoms of muscle weakness (whether the patient think a test was difficult to complete or uncomfortable to perform), recorded as normal (negative response) or impaired (positive response)	Assessed upon arrival at PACU, after 20 minutes at PACU and after 90 minutes at PACU