Opioid Free AnesthesiaNCT06650371
Opioid Free Anesthesia Versus Opioid Based Anesthesia
A study testing Fentanyl infusion and Dexamedomedine and ketamine infusion in people with Opioid Free Anesthesia and Laparoscopic Bariatric Surgeries, run by Ain Shams University.
Trial summary
This Study aims to evaluate the efficacy of opioid free general anesthesia in achieving enhanced recovery after surgery (ERAS) in laparoscopic bariatric surgery in terms of post-operative recovery time, cumulative pethidine consumption and number of episodes of postoperative nausea and vomiting(PONV). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Free Anesthesia, Laparoscopic Bariatric Surgeries
- What is being tested?
- Fentanyl infusion and Dexamedomedine and ketamine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing a scheduled laparoscopic bariatric surgery under general anesthesia.
- Age group: 18-65 years old.
- BMI greater than 35 to 50 Kg/m2
- ASA physical status classes I and II.
Who cannot join
- Patient refusal.
- ASA physical status classes III and IV.
- Anticipated difficult intubation.
- Hypersensitivity to any drugs used in this study. Inability to extubate the patient at the end of the operation. Conversion to laparotomy. Patients for whom the anesthetic regimen is changed intraoperatively (from OFA to OBA or vice versa).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Eman Zain contact
About this study
Official title: Comparative Study Between the Performance of Opioid Free Anesthesia Versus Conventional Opioid Based Anesthesia Regarding Achievement of Enhanced Recovery in Laparoscopic Bariatric Surgeries
This Study aims to evaluate the efficacy of opioid free general anesthesia in achieving enhanced recovery after surgery (ERAS) in laparoscopic bariatric surgery in terms of post-operative recovery time, cumulative pethidine consumption and number of episodes of postoperative nausea and vomiting(PONV).
Read the detailed description
While opioids have been commonly used in the operating room due to their effectiveness in pain management and anesthesia, there are numerous common side effects that have an impact on patient recovery. Obese patients or those with pre-existing respiratory difficulties such as sleep apnea or chronic obstructive pulmonary disease are more likely to experience respiratory failure after getting opiate therapy. Other effects of opioid use include gastro-intestinal obstacles such nausea, vomiting, and constipation.
The concept of opioid-free anesthesia evolved due to the potential adverse side effects associated with intraoperative opioid usage.
This study examines nociceptive monitoring's potential role in opioid-free anesthesia, as well as research on the topic. This study aims to compare the effects of an opioid-free anesthesia (OFA) regimen versus an opioid-based anesthesia (OBA) regimen on postoperative pain and enhanced recovery in patients undergoing bariatric surgery.
- Being tested
- Fentanyl infusion, Dexamedomedine and ketamine infusion
- Keywords
- Opioid free anesthesia, laparoscopic bariatric surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl infusionDrug
opioid based anesthesia analgesia will be offered by fentanyl in induction and maintenance according to Ideal Body Weight (IBW).
Dexamedomedine and ketamine infusionDrug
Analgesia will be offered by syringe containing ketamine and Dexmedetomidine in induction and maintenance according to IBW.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl infusion | Active comparator | Analgesia will be offered by fentanyl in induction and maintenance according to ideal body weight (IBW). Receives: Drug: Fentanyl infusion |
| Dexamedomedine and ketamine infusion | Active comparator | Opioid free anesthesia Analgesia will be offered by syringe containing ketamine and dexmedetomidine in induction and maintenance according to IBW. Receives: Drug: Dexamedomedine and ketamine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time between the end of analgesic used and an Aldrete score > 9 (when applicable).
Decrease opioid usage ,decrease recovery time
Measured: 15 minutes
Time between the end of operation to PACU
Decrease opioid usage ,decrease recovery time
Measured: 15 minutes
Secondary outcomes (2)
Cumulative pethidine consumption
decrease the need to postoperative pethidine
Measured: 24 hours postoperative
Number of episodes of nausea and vomiting [Time Frame: During the 24 hours following extubation].
number of episodes of nausea and vomiting postoperative
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start20 Nov 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Free AnesthesiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed Zain Eldeen, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650371
- Sponsor's protocol ID
- FMASU MD126/2024
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Performance of Opioid Free Anesthesia Versus Conventional Opioid Based Anesthesia Regarding Achievement of Enhanced Recovery in Laparoscopic Bariatric Surgeries
- ClinicalTrials.gov ID
- NCT06650371
- Acronym / sponsor ID
- FMASU MD126/2024
- Keywords
- Opioid free anesthesia, laparoscopic bariatric surgeries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 21 Oct 2024 (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.
This Study aims to evaluate the efficacy of opioid free general anesthesia in achieving enhanced recovery after surgery (ERAS) in laparoscopic bariatric surgery in terms of post-operative recovery time, cumulative pethidine consumption and number of episodes of postoperative nausea and vomiting(PONV).
Detailed description
While opioids have been commonly used in the operating room due to their effectiveness in pain management and anesthesia, there are numerous common side effects that have an impact on patient recovery. Obese patients or those with pre-existing respiratory difficulties such as sleep apnea or chronic obstructive pulmonary disease are more likely to experience respiratory failure after getting opiate therapy. Other effects of opioid use include gastro-intestinal obstacles such nausea, vomiting, and constipation.
The concept of opioid-free anesthesia evolved due to the potential adverse side effects associated with intraoperative opioid usage.
This study examines nociceptive monitoring's potential role in opioid-free anesthesia, as well as research on the topic. This study aims to compare the effects of an opioid-free anesthesia (OFA) regimen versus an opioid-based anesthesia (OBA) regimen on postoperative pain and enhanced recovery in patients undergoing bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl infusion | Active comparator | Drug: Fentanyl infusionAnalgesia will be offered by fentanyl in induction and maintenance according to ideal body weight (IBW). |
| Dexamedomedine and ketamine infusion | Active comparator | Drug: Dexamedomedine and ketamine infusionOpioid free anesthesia Analgesia will be offered by syringe containing ketamine and dexmedetomidine in induction and maintenance according to IBW. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing a scheduled laparoscopic bariatric surgery under general anesthesia.
- Age group: 18-65 years old.
- BMI greater than 35 to 50 Kg/m2
- ASA physical status classes I and II.
Key exclusion criteria (4 listed)
- Patient refusal.
- ASA physical status classes III and IV.
- Anticipated difficult intubation.
- Hypersensitivity to any drugs used in this study. Inability to extubate the patient at the end of the operation. Conversion to laparotomy. Patients for whom the anesthetic regimen is changed intraoperatively (from OFA to OBA or vice versa).
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 |
|---|---|---|
| Fentanyl infusionopioid based anesthesia analgesia will be offered by fentanyl in induction and maintenance according to Ideal Body Weight (IBW). | Drug | Fentanyl infusion |
| Dexamedomedine and ketamine infusionAnalgesia will be offered by syringe containing ketamine and Dexmedetomidine in induction and maintenance according to IBW. | Drug | Dexamedomedine and ketamine infusion |
Primary outcome
Time between the end of analgesic used and an Aldrete score > 9 (when applicable).
Time frame: 15 minutes
Decrease opioid usage ,decrease recovery time
Time between the end of operation to PACU
Time frame: 15 minutes
Decrease opioid usage ,decrease recovery time
2 secondary outcomes
Cumulative pethidine consumption
Time frame: 24 hours postoperative
Number of episodes of nausea and vomiting [Time Frame: During the 24 hours following extubation].
Time frame: 24 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
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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.
Eman Zain contact
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl infusion and Dexamedomedine and ketamine infusion in people with Opioid Free Anesthesia and Laparoscopic Bariatric Surgeries, run by Ain Shams University.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman Mohamed Zain (01017254024, emanzain@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time between the end of analgesic used and an Aldrete score > 9 (when applicable). (time frame: 15 minutes). The study lists 2 primary outcomes in all. 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 21 Oct 2024.