Overview
Sponsor-declared trial summary
bariatric surgery
To evaluate the effect of Opioid-Free Anesthesia on the Arterial Oxygen Pressure/Inspired Fraction of Oxygen (PaO2/FiO2) ratio during the first 6 postoperative hours in comparison with conventional anesthesia.
Key facts
- Sponsor
- Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Decision date (initial)
- 2024-11-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519722-20-00
- EudraCT number
- 2022-001027-33
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To evaluate the effect of Opioid-Free Anesthesia on the Arterial Oxygen Pressure/Inspired Fraction of Oxygen (PaO2/FiO2) ratio during the first 6 postoperative hours in comparison with conventional anesthesia.
Secondary objectives 6
- Assess the effects on ventilation by measuring the partial pressure of oxygen (PCO2).
- To evaluate hemodynamic stability, by comparing blood pressure (BP) and baseline heart rate, after intubation, after surgical stimulation and upon arrival at the post-anesthesia resuscitation unit (PACU).
- To evaluate pain control and postoperative morphine consumption.
- Assess postoperative nausea and vomiting
- Evaluate postsurgical recovery and duration of hospital stay
- Evaluate costs
Conditions and MedDRA coding
bariatric surgery
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10018061 | General anesthesia | 10042613 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients aged 18 or over
- Patients pending laparoscopic vertical gastrectomy for bariatric surgery.
- Give informed consent
Exclusion criteria 5
- Advanced heart block (grade 2 or 3 in the absence of a pacemaker).
- Preoperative renal dysfunction, estimated through the preoperative GFR rate (creatinine clearance < 50ml/min).
- Liver failure
- Hypersensitivity to gabapentin, lidocaine, dexmedetomidine, ketamine, NSAIDs, paracetamol or Magnesium Sulfate.
- Myasthenia gravis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To evaluate the effect of Opioid-Free Anesthesia on the Arterial Oxygen Pressure/Inspired Fraction of Oxygen (PaO2/FiO2) ratio during the first 6 postoperative hours in comparison with conventional anesthesia.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
KETOLAR 50 mg/ml solución inyectable.
PRD358161 · Product
- Active substance
- Ketamine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 1.1 % (V/V) percent volume/volume
- Max total dose
- 1.1 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX03 — KETAMINE
- Marketing authorisation
- 47.034
- MA holder
- PFIZER S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
- Sponsor organisation
- Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
- Address
- Calle De Severo Ochoa 35, Parque Tecnologico De Andalucia Parque Tecnologico De Andalucia
- City
- Malaga
- Postcode
- 29590
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
- Contact name
- Elvira Bonilla
Public contact point
- Organisation
- Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
- Contact name
- Elvira Bonilla
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud ORG-100029161
|
Malaga, Spain | Code 5 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 72 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocolo V 1014022020 | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements_signed | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements_signed | 1 |
| Subject information and informed consent form (for publication) | CIPaFi | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | ketamina | 1 |
| Synopsis of the protocol (for publication) | Synopsis of the protocol | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-18 | Spain | Acceptable 2024-11-20
|
2024-11-20 |