Clinical trial • Not applicable • Other

SUGAMMADEX SODIUM for General anesthesia

Not applicable trial of SUGAMMADEX SODIUM for General anesthesia. open-label. 10 participants. CTIS 2024-516415-24.

Overview

Trial Therapeutic Area
Other
Trial Disease
General anesthesia
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
21-08-2025
First CTIS Authorization Date
02-12-2025

Trial design

open-label Not applicable trial across 1 site in Netherlands.

Open Label
Yes
Target Sample Size
10
Trial Duration For Participant
1

Eligibility

Recruits 10 No vulnerable population selected (isVulnerablePopulationSelected=false). Participants are healthy volunteers aged 18-65. Informed consent is required (see 'L1_SIS and ICF 2024-516415-24 clean version' subject information and ICF document)..

Pregnancy Exclusion
Pregnancy (anamnestic or use of oral anticonceptives). One of the medicines we use (sugammadex) can temporarily increase the risk of pregnancy. This is equivalent to one missed pill
Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected=false). Participants are healthy volunteers aged 18-65. Informed consent is required (see 'L1_SIS and ICF 2024-516415-24 clean version' subject information and ICF document).

Inclusion criteria

  • {"criterion_text":"-Age 18-65"}
  • {"criterion_text":"-ASA ≤ II (no systemic diseases, including cardiac, pulmonary, liver and kidney diseas-es or epilepsy)"}

Exclusion criteria

  • {"criterion_text":"-No informed consent"}
  • {"criterion_text":"-Allergic reaction for one of the used agents"}
  • {"criterion_text":"-Expected or known difficult airway"}
  • {"criterion_text":"-BMI > 30"}
  • {"criterion_text":"-Pregnancy (anamnestic or use of oral anticonceptives). One of the medicines we use (sugammadex) can temporarily increase the risk of pregnancy. This is equivalent to one missed pill"}
  • {"criterion_text":"-ASA > II"}
  • {"criterion_text":"-Systemic diseases or epilepsy"}
  • {"criterion_text":"-Use of alcohol < 24 hr and drugs < 48 hr before start of the trial"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Time to the return of spontaneous breathing","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"-Time to opening the eyes","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Time to return of airway reflexes (swallow-ing, coughing)","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Respiratory effects (saturation, respiratory rate, capnography)","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Hemodynamic effects (blood pressure, heart rate)","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Bispectral Index Score (BIS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Neuromuscular block depth","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Physician satisfaction","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Total time to emerge from anaesthesia (to-tally awake, as before induction)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
10
Recruitment Window Months
12
Consent Approach
Informed consent is required from adult participants (healthy volunteers aged 18-65). Subject information and informed consent form is provided ('L1_SIS and ICF 2024-516415-24 clean version'). No assent or minor consent arrangements are indicated. Protocol synopses are available in English and Dutch.

Geography

Total Number Of Sites
1
Total Number Of Participants
10

Netherlands

Earliest CTIS Part Ii Submission Date
26-11-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
6
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Anesthesiology
Contact Person Name
Rebecca Koch
Contact Person Email
rebecca.koch@radboudumc.nl
Number Of Participants
10

Sponsor

Primary sponsor

Full Name
Stichting Radboud universitair medisch centrum
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Sugammadex hameln 100 mg/ml oplossing voor injectie
Active Substance
SUGAMMADEX SODIUM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Authorisation Status
Authorised
Maximum Dose
16 mg/Kg
Investigational Product Name
Naloxon HCl Accord 0,4 mg/ml, oplossing voor injectie / infusie in een voorgevulde spuit
Active Substance
NALOXONE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Authorisation Status
Authorised
Maximum Dose
2 mg/Kg
Investigational Product Name
ANEXATE 0,5 mg/5 ml, solution injectable (I.V.)
Active Substance
FLUMAZENIL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Authorisation Status
Authorised
Maximum Dose
2 mg
Investigational Product Name
REMIMAZOLAM
Active Substance
REMIMAZOLAM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
Investigational (no marketing authorisation provided)
Maximum Dose
33 mg
Investigational Product Name
Sufentanil Viatris 5 microgram/ml oplossing voor injectie
Active Substance
SUFENTANIL CITRATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Authorisation Status
Authorised
Maximum Dose
5 µg/Kg
Investigational Product Name
Esmeron 10 mg/ml, oplossing voor injectie
Active Substance
ROCURONIUM BROMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS ADMINISTRATION
Authorisation Status
Authorised
Maximum Dose
2 mg/Kg
Combination Treatment
Yes

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