AnesthesiaPhase 4NCT05962671
Opioid-sparing Versus Sevoflurane Anesthesia on Early Postoperative Hypoventilation in Laparoscopic Bariatric Surgery
A Phase 4 study testing Opioid-sparing based anesthesia and Sevoflurane-based anesthesia in people with Anesthesia and Hypoventilation, run by Tanta University at 1 site in Egypt.
Trial summary
Determine the incidence of early post-operative hypoventilation in post-anesthesia care unit (PACU) in patients undergoing laparoscopic bariatric surgery under opioid-sparing compared with sevoflurane-based anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Hypoventilation, Opioid Use
- What is being tested?
- Opioid-sparing based anesthesia and Sevoflurane-based anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2023to 30 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients ≥ 18 years
- Admitted to the post anesthesia care unit after bariatric surgery
Who cannot join
- Preoperative hypoxemia which is determined by a peripheral capillary oxygen saturation (SPO2) reading of < 90% on room air
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Tanta University
Tanta, El-Gharbia, 31527
Samah M Marie, MBBCH, +20 120 745 203, mohamedsamah084@gmail.com
About this study
Official title: Opioid-sparing Versus Sevoflurane-based Anesthesia on Early Postoperative Hypoventilation in Patients Undergoing Laparoscopic Bariatric Surgery: Prospective Randomized Study
Determine the incidence of early post-operative hypoventilation in post-anesthesia care unit (PACU) in patients undergoing laparoscopic bariatric surgery under opioid-sparing compared with sevoflurane-based anesthesia.
Read the detailed description
The incidence of early postoperative hypoxemia in the literature is diverse, this may be due to multivariable, including patient-related factors, anesthesia-related factors, and surgery-related factors. Because of the controverse regarding the incidence of postoperative hypoxemia and the evidence of anesthetic technique of choice, interest in prevention and early management of early postoperative hypoxemia after laparoscopic bariatric surgery is continued.
- Conditions
- Anesthesia, Hypoventilation, Opioid Use, Bariatric Surgery
- Being tested
- Opioid-sparing based anesthesia, Sevoflurane-based anesthesia
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid-sparing based anesthesiaDrug
Also called Opioid
Intraoperative opioid-sparing maintenance comprised dexmedetomidine bolus dose of 1 mcg/kg followed by 0.3 mcg/kg/h, propofol 4-8 mg/kg/h and ketamine 25 mg/h for a max of 50 mg during the procedure, targeting bispectral index (BIS) between 45%-60%. The lean body weight will be used for calculation of the drugs.
Sevoflurane-based anesthesiaDrug
Also called Sevoflurane
Intraoperative sevoflurane-based anesthesia, 0.8 to 1.0 Minimum alveolar concentration will be used combined with fentanyl 1 mcg/kg followed by 1 -2 mcg/kg/h and cis-atracurium, to keep bispectral index between 45% to 60%.
| Study group | Role | What they receive |
|---|---|---|
| Opioid-sparing based anesthesia | Active comparator | Intraoperative opioid-sparing maintenance comprised dexmedetomidine bolus dose of 1 mcg/kg followed by 0.3 mcg/kg/h, propofol 4-8 mg/kg/h and ketamine 25 mg/h for a max of 50 mg during the procedure, targeting bispectral index (BIS) between 45%-60%. The lean body weight will be used for calculation of the drugs. Receives: Drug: Opioid-sparing based anesthesia |
| Sevoflurane-based anesthesia | Active comparator | Intraoperative sevoflurane-based anesthesia, 0.8 to 1.0 Minimum alveolar concentration will be used combined with fentanyl 1 mcg/kg followed by 1 -2 mcg/kg/h and cis-atracurium, to keep bispectral index between 45% to 60%. Receives: Drug: Sevoflurane-based anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Early postoperative hypoventilation
Early postoperative respiratory hypoventilation will be defined by any of the following parameters:
Oxygen saturation < 95% for 10 seconds. Respiratory rate < 8 breath/min. Apnea spill > 10 seconds. pain/sedation-mismatch.
Measured: UP to 24 hours Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start10 Aug 2023 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Mohamed Marie, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962671
- Sponsor's protocol ID
- 36264MS154/4/23
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-sparing Versus Sevoflurane-based Anesthesia on Early Postoperative Hypoventilation in Patients Undergoing Laparoscopic Bariatric Surgery: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05962671
- Acronym / sponsor ID
- 36264MS154/4/23
- Conditions
- Anesthesia, Hypoventilation, Opioid Use, Bariatric Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the incidence of early post-operative hypoventilation in post-anesthesia care unit (PACU) in patients undergoing laparoscopic bariatric surgery under opioid-sparing compared with sevoflurane-based anesthesia.
Detailed description
The incidence of early postoperative hypoxemia in the literature is diverse, this may be due to multivariable, including patient-related factors, anesthesia-related factors, and surgery-related factors. Because of the controverse regarding the incidence of postoperative hypoxemia and the evidence of anesthetic technique of choice, interest in prevention and early management of early postoperative hypoxemia after laparoscopic bariatric surgery is continued.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-sparing based anesthesia | Active comparator | Drug: Opioid-sparing based anesthesiaIntraoperative opioid-sparing maintenance comprised dexmedetomidine bolus dose of 1 mcg/kg followed by 0.3 mcg/kg/h, propofol 4-8 mg/kg/h and ketamine 25 mg/h for a max of 50 mg during the procedure, targeting bispectral index (BIS) between 45%-60%. The lean body weight will be used for calculation of the drugs. |
| Sevoflurane-based anesthesia | Active comparator | Drug: Sevoflurane-based anesthesiaIntraoperative sevoflurane-based anesthesia, 0.8 to 1.0 Minimum alveolar concentration will be used combined with fentanyl 1 mcg/kg followed by 1 -2 mcg/kg/h and cis-atracurium, to keep bispectral index between 45% to 60%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients ≥ 18 years
- Admitted to the post anesthesia care unit after bariatric surgery
Key exclusion criteria (1 listed)
- Preoperative hypoxemia which is determined by a peripheral capillary oxygen saturation (SPO2) reading of < 90% on room air
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid-sparing based anesthesiaAlso: OpioidIntraoperative opioid-sparing maintenance comprised dexmedetomidine bolus dose of 1 mcg/kg followed by 0.3 mcg/kg/h, propofol 4-8 mg/kg/h and ketamine 25 mg/h for a max of 50 mg during the procedure, targeting bispectral index (BIS) between 45%-60%. The lean body weight will be used for calculation of the drugs. | Drug | Opioid-sparing based anesthesia |
| Sevoflurane-based anesthesiaAlso: SevofluraneIntraoperative sevoflurane-based anesthesia, 0.8 to 1.0 Minimum alveolar concentration will be used combined with fentanyl 1 mcg/kg followed by 1 -2 mcg/kg/h and cis-atracurium, to keep bispectral index between 45% to 60%. | Drug | Sevoflurane-based anesthesia |
Primary outcome
Incidence of Early postoperative hypoventilation
Time frame: UP to 24 hours Postoperatively
Early postoperative respiratory hypoventilation will be defined by any of the following parameters: Oxygen saturation < 95% for 10 seconds. Respiratory rate < 8 breath/min. Apnea spill > 10 seconds. pain/sedation-mismatch.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Opioid-sparing based anesthesia and Sevoflurane-based anesthesia in people with Anesthesia and Hypoventilation, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samah M Marie, MBBCh (+20 120 745 203, mohamedsamah084@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Early postoperative hypoventilation (time frame: UP to 24 hours Postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.