A blinded randomized study of two types of reversal agents (neostigmine/glycopyrrolate 50 mikrogram/kg or sugammadex 2 mg/kg) for reversal of neuromuscular blockade in elderly patients (≥ 75 years)

2023-504230-21-00 Therapeutic use (Phase IV) Ended

Start 12 Aug 2024 · End 4 May 2025 · Status Ended · 1 EU/EEA countries · 3 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ended
Participants planned 1
Countries 1
Sites 3

Anaesthesia to laparoscopic robotassisted surgery

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.

Key facts

Sponsor
Rigshospitalet, Rigshospitalet
Participant type
Patients
Age range
65+ years
Gender
Male and Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Trial duration
12 Aug 2024 → 4 May 2025
Decision date (initial)
2023-06-07
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic

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.

Conditions and MedDRA coding

Anaesthesia to laparoscopic robotassisted surgery

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 A blinded randomized study of reversal with neostigmine/glycopyrrolate or sugammadex in elderly
A blinded randomized study of neostigmine/glycopyrrolate 50 mikrogram/kg or sugammadex 2 mg/kg for reversal of neuromuscular blockade in elderly patients (≥ 75 years).
 Randomised Controlled Single [{"id":114276,"code":5,"name":"Carer"}] neostigmine: administration of neostigmine/glycopyrrolate 50 mikrogram/kg when TOF count is 2
sugammadex: administration of sugammadex 2 mg/kg when TOF count is 2

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. 1) Patients ≥ 75 years old
  2. 2) Informed consent
  3. 3) Scheduled for robotic assisted laparoscopic surgery under general anesthesia with intubation and use of rocuronium during the entire operation
  4. 4) American Society of Anesthesiologists (ASA) physical status classification I to IV
  5. 5) Can read and understand Danish

Exclusion criteria 4

  1. 1) Known allergy to rocuronium, sugammadex or neostigmine/glycopyrrolate
  2. 2) Neuromuscular disease that may interfere with neuromuscular data
  3. 3) Severe renal impairment defined as eGFR < 30 ml/min
  4. 4) Indication for rapid sequence induction

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Time to TOF > 0.9 (from beginning of administration of reversal agent until TOF > 0.9)

Secondary endpoints 5

  1. • Key secondary outcome is sign of residual neuromuscular blockade within 90 minutes after administration of reversal agent defined as a composite (assessed upon arrival at PACU after 20 minutes and after 90 minutes) of either o Hand grip strength for 5 seconds or o Occurrence of double vision/blurred vision (yes/no) or o Ability to track objects with eyes (follow finger of examiner) (yes/no) or o Ability to sustain head lift for 5 seconds (yes/no) or o Ability to protrude the tongue for 5 seco
  2. • Occurrence of episodes of desaturation defined as more than 3 minutes with spO2 < 88%
  3. • 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
  4. • Occurrence of reintubation
  5. • Time from administration of reversal agent to patient is ready to leave the operating room

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Bridion 100 mg/mL solution for injection

PRD2814566 · Product

Active substance
Sugammadex
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
16 mg/kg milligram(s)/kilogram
Max total dose
16 mg/kg milligram(s)/kilogram
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
V03AB35 — -
Marketing authorisation
EU/1/08/466/002
MA holder
MERCK SHARP & DOHME BV
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 1

Robinul-Neostigmin, injektionsvæske, opløsning

PRD840883 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
50 µg/Kg microgram(s)/kilogram
Max total dose
50 µg/Kg microgram(s)/kilogram
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
N07AA51 — NEOSTIGMINE, COMBINATIONS
Marketing authorisation
13059
MA holder
VIATRIS APS
MA country
Denmark
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

94 Total trials 54 Recruiting 24 Ended
Academic / Non-commercial
Sponsor organisation
Rigshospitalet
Address
Blegdamsvej 9
City
Copenhagen Oe
Postcode
2100
Country
Denmark

Scientific contact point

Organisation
Rigshospitalet
Contact name
Matias Vested

Public contact point

Organisation
Rigshospitalet
Contact name
Matias Vested

Third parties 1

OrganisationCity, countryDuties
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark On site monitoring

Rigshospitalet

94 Total trials 54 Recruiting 24 Ended
Academic / Non-commercial
Sponsor organisation
Rigshospitalet
Address
Blegdamsvej 9
City
Copenhagen Oe
Postcode
2100
Country
Denmark

Locations

1 EU/EEA country · 3 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ended 1 3
Rest of world — 0 —

Investigational sites

Denmark

3 sites · Ended
Rigshospitalet
Anaesthesia JMC, Blegdamsvej 9, 2100, Copenhagen Oe
Bispebjerg Hospital
Anaesthesia, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Rigshospitalet
Anaesthesia HOC, Blegdamsvej 9, 2100, Copenhagen Oe

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2024-08-12 2025-05-04 2024-08-12 2025-05-01

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Protocol reversal neo vs sug elderly 10
Protocol (for publication) Protocol reversal neo vs sug elderly_with_changes 11
Protocol (for publication) Protocol reversal neo vs sug elderly_without_changes161023 11
Recruitment arrangements (for publication) recruitment strategy reversal 1
Subject information and informed consent form (for publication) Deltagerinformation - ldre - revertering_changes2806 3
Subject information and informed consent form (for publication) Deltagerinformation - ldre - revertering_clean2806 3
Subject information and informed consent form (for publication) Dine rettigheder som forsgsperson i forsg med medicin 1
Subject information and informed consent form (for publication) Protokolresume - ldre - revertering 1
Subject information and informed consent form (for publication) Samtykkeerklring revertering 1
Summary of Product Characteristics (SmPC) (for publication) bridion-epar-product-information_da 1
Summary of Product Characteristics (SmPC) (for publication) Robinul-Neostigmin 1
Synopsis of the protocol (for publication) Protokolresume - ldre - revertering 1

Application history

5 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-03-10 Denmark Acceptable
2023-05-31
 2023-06-07
2 SUBSTANTIAL MODIFICATION SM-1 2023-06-25 Denmark Acceptable 2023-06-30
3 SUBSTANTIAL MODIFICATION SM-5 2023-10-16 Denmark Acceptable
2023-11-01
 2023-11-02
4 NON SUBSTANTIAL MODIFICATION NSM-2 2024-08-12 Denmark Acceptable
2023-11-01
 2024-08-12
5 SUBSTANTIAL MODIFICATION SM-6 2025-03-07 Denmark Acceptable
2025-03-12
 2025-03-12