Clinical trial • Not applicable • Other
Ketamine hydrochloride for Bariatric surgery
Not applicable trial of Ketamine hydrochloride for Bariatric surgery.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Bariatric surgery
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 18-11-2024
- First CTIS Authorization Date
- 20-11-2024
Trial design
Conventional anesthesia (comparator; not specified drug, dose, or schedule)-controlled Not applicable trial across 1 site in Spain.
- Comparator
- Conventional anesthesia (comparator; not specified drug, dose, or schedule)
- Target Sample Size
- 72
Eligibility
Recruits 72 No vulnerable population selected. Participants must give informed consent (patients aged 18 or over)..
- Vulnerable Population
- No vulnerable population selected. Participants must give informed consent (patients aged 18 or over).
Inclusion criteria
- {"criterion_text":"- Patients aged 18 or over"}
- {"criterion_text":"- Patients pending laparoscopic vertical gastrectomy for bariatric surgery."}
- {"criterion_text":"- Give informed consent"}
Exclusion criteria
- {"criterion_text":"- Advanced heart block (grade 2 or 3 in the absence of a pacemaker)."}
- {"criterion_text":"- Preoperative renal dysfunction, estimated through the preoperative GFR rate (creatinine clearance < 50ml/min)."}
- {"criterion_text":"- Liver failure"}
- {"criterion_text":"- Hypersensitivity to gabapentin, lidocaine, dexmedetomidine, ketamine, NSAIDs, paracetamol or Magnesium Sulfate."}
- {"criterion_text":"- Myasthenia gravis"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measurement of the Arterial Oxygen Pressure/Inspired Fraction of Oxygen (PaO2/FiO2) ratio during the first 6 postoperative hours; comparison between Opioid-Free Anesthesia and conventional anesthesia."}
Recruitment
- Planned Sample Size
- 72
- Recruitment Window Months
- 17
- Consent Approach
- Written informed consent obtained from participants (patients aged 18 or over). A subject information and informed consent form document is listed for publication. Spanish translations of trial documents are available.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 72
Spain
- Earliest CTIS Part Ii Submission Date
- 18-11-2024
- Latest Decision Or Authorization Date
- 20-11-2024
- Processing Time Days
- 2
- Number Of Sites
- 1
- Number Of Participants
- 72
Sites
- Site Name
- Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
- Department Name
- Anestesia y Reanimacion
- Contact Person Name
- Alfredo Malo
- Contact Person Email
- elvira.bonilla@ibima.eu
- Number Of Participants
- 72
Sponsor
Primary sponsor
- Full Name
- Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Third parties
- {"country":"Spain","full_name":"Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud","duties_or_roles":"sponsorDuties code 5","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- KETOLAR 50 mg/ml solución inyectable.
- Active Substance
- Ketamine hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- Intravenous administration
- Route
- Intravenous administration
- Authorisation Status
- Marketing authorisation in Spain (marketingAuthNumber 47.034; prodAuthStatus 2)
- Maximum Dose
- maxTotalDoseAmount 1.1 % (V/V) (as listed in product attributes)
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