Clinical trial • Phase IV • Other
NITROUS OXIDE; OXYGEN for Surgery under general anesthesia
Phase IV trial of NITROUS OXIDE; OXYGEN for Surgery under general anesthesia.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Surgery under general anesthesia
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 14-08-2024
- First CTIS Authorization Date
- 29-10-2024
Trial design
Randomised, routine use with fixed oxygen concentrations (oxygen inhalation gas). specific fixed concentration values or schedule not specified in the record.-controlled Phase IV trial across 3 sites in Sweden.
- Randomised
- Yes
- Comparator
- Routine use with fixed oxygen concentrations (oxygen inhalation gas). Specific fixed concentration values or schedule not specified in the record.
- Target Sample Size
- 200
- Trial Duration For Participant
- 90
Eligibility
Recruits 200 Vulnerable population not selected. Only adults (> 18 years old) are eligible. The subject must give written consent to participate. Inability to understand written or verbal information, thereby hindering the ability to provide informed consent, is an exclusion criterion..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- Vulnerable population not selected. Only adults (> 18 years old) are eligible. The subject must give written consent to participate. Inability to understand written or verbal information, thereby hindering the ability to provide informed consent, is an exclusion criterion.
Inclusion criteria
- {"criterion_text":"- Adults (> 18 years old)\n- The subject has given their written consent to participate in the trial.\n- Be scheduled for abdominal surgery performed at the Departments of Surgery, Urology and Gynecology lasting more than 2 hours.\n- Fall under the American Society of Anesthesia (ASA) Class 1-3."}
Exclusion criteria
- {"criterion_text":"- Increased risk for difficult intubation during anesthesia (Mallampati score 3-4) or previous documentation of difficult intubation.\n- The inability to understand written or verbal information, thereby hindering the ability to provide informed consent.\n- Obese with a BMI >35 kg/m2.\n- Participation or recent participation within 30 days in a clinical trial with an investigational medicinal product. Previous participation in this trial.\n- Pregnancy"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Arterial oxygen partial pressure (PaO2) measured on postoperative day 2 compared to the day before surgery. Supplemental oxygen will be ceased before the blood sampling, if possible, for 30 minutes or longer.","definition_or_measurement_approach":"PaO2 measured on postoperative day 2 and compared to preoperative day; supplemental oxygen stopped before sampling for 30 minutes or longer when possible."}
Secondary endpoints
- {"endpoint_text":"- Change in diffusion capacity for carbon monoxide on day 2 and after 3 months compared to the day preceding surgery (=baseline).\n- Change in vital capacity (VC) on day 2 and after 3 months compared to baseline.\n- Change in PaO2 and PaCO2 on day 1 and after 3 months compared to baseline.\n- Surgical site infections within 30 days of surgery.\n- Postoperative recovery using the Postoperative Recovery Profile at discharge and after 3 months\n- Hospital length of stay.\n- Effect of background variables on outcomes, including age, sex, height, weight, body mass index (BMI), type of surgery, duration of surgery, and type of anesthesia.","definition_or_measurement_approach":"Change in DLCO: measured on day 2 and at 3 months vs preoperative baseline. Vital capacity: measured on day 2 and at 3 months vs baseline. PaO2 and PaCO2: measured on day 1 and at 3 months vs baseline. Surgical site infections: monitored within 30 days post-surgery. Postoperative recovery: assessed using the Postoperative Recovery Profile at discharge and at 3 months. Hospital length of stay: recorded in days. Effect of background variables: exploratory analysis assessing impact of age, sex, height, weight, BMI, type and duration of surgery, and type of anesthesia on outcomes."}
Recruitment
- Planned Sample Size
- 200
- Recruitment Window Months
- 24
- Consent Approach
- Written informed consent is required from each participant (adults). A subject information and informed consent form document is available (document: 'Information till forsoksperson'). No assent for minors is applicable (only adults eligible). Languages available not specified.
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 200
Sweden
- Earliest CTIS Part Ii Submission Date
- 10-10-2024
- Latest Decision Or Authorization Date
- 29-10-2024
- Processing Time Days
- 19
- Number Of Sites
- 3
- Number Of Participants
- 200
Sites
- Site Name
- Region Norrbotten
- Department Name
- Department of anesthesiology and intensive care medicin
- Contact Person Name
- Tomi Myrberg
- Contact Person Email
- tomi.myrberg@umu.se
- Site Name
- Region Vaesterbotten
- Department Name
- Department of surgery
- Contact Person Name
- Karl Franklin
- Contact Person Email
- karl.franklin@umu.se
- Site Name
- Region Vaesternorrland
- Department Name
- Department of anesthesiology and intensive care medicin
- Contact Person Name
- Jakob Wallden
- Contact Person Email
- jakob.wallden@umu.se
Sponsor
Primary sponsor
- Full Name
- Region Vaesterbotten
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Co-sponsors
- Umea University
Investigational products
- Investigational Product Name
- OXYGEN
- Active Substance
- NITROUS OXIDE; OXYGEN
- Modality
- Small molecule
- Routes Of Administration
- INHALATION GAS
- Route
- INHALATION GAS
- Authorisation Status
- Marketing authorisation number: -; product authorisation status code: 2
- Maximum Dose
- 100% (maxDailyDoseAmount/maxTotalDoseAmount 100)
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