Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy
NCT ID: NCT04285255
Last Updated: 2021-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
103 participants
INTERVENTIONAL
2020-03-01
2020-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Opioids anesthesia
received propofol-fentanyl induction of anaesthesia plus ultrasound-guided Bilateral oblique subcostal TAP block using 20ml of bupivacaine hydrochloride 0.25% (Marcaine, Astra Zeneca UK) in each side (total volume of 40 ml) deposited equally on each side
Fentanyl
opioids anaesthesia
Oblique subcostal transversus abdominis plane block
Bupivacaine 0.25% injected under ultrasound usage in the transversus abdominis plane
OFA
received preinduction with dexmeditomidine 0.1µg.kg-1 over 10 min. Induction with propofol 1.5 mg.kg-1-ketamine (ketofol 3:1 mixture) induction plus maintenance mixture of dexmedetomidine 0.5µg.kg-1.h-1, ketamine 0.5mg.kg-1.h-1, and lidocaine 1 mg.kg-1.h-1 plus ultrasound-guided Bilateral oblique subcostal TAP block using 20ml of bupivacaine hydrochloride 0.25% (Marcaine, Astra Zeneca UK) in each side (total volume of 40 ml) deposited equally on each side
Ketamine
ketamine induction and analgesia as opioids free anaesthesia versus opioids analgesia
Dexmedetomidine Injection [Precedex]
alpha 2 agonist with sedative, analgesic effect
Oblique subcostal transversus abdominis plane block
Bupivacaine 0.25% injected under ultrasound usage in the transversus abdominis plane
Lidocaine
infusion of lidocaine 2%(1mg/kg/h)
Interventions
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Fentanyl
opioids anaesthesia
Ketamine
ketamine induction and analgesia as opioids free anaesthesia versus opioids analgesia
Dexmedetomidine Injection [Precedex]
alpha 2 agonist with sedative, analgesic effect
Oblique subcostal transversus abdominis plane block
Bupivacaine 0.25% injected under ultrasound usage in the transversus abdominis plane
Lidocaine
infusion of lidocaine 2%(1mg/kg/h)
Eligibility Criteria
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Inclusion Criteria
* Elective laparoscopic bariatric surgery.
* Body mass index (BMI) is from 40 to 60
* Trocar sites at or above the umbilicus (T 10 dermatome).
Exclusion Criteria
* presence of coagulopathy
* local skin infection at injection sites,
* preoperative chronic dependence upon opioid and NSAID medications,
* liver or renal insufficiency,
* history of psychiatric or neurological disease, deafness,
* previous open surgery,
* patients who need to be converted to open surgery with more tissue trauma,
* ASA (American society of anesthesiologists) class above III were excluded.
18 Years
60 Years
ALL
Yes
Sponsors
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Al Mashfa Medical Center
OTHER
Responsible Party
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Locations
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Al Mashfa medical center
Khobar, Eastern Provence, Saudi Arabia
Countries
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References
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Ibrahim M, Elnabtity AM, Hegab A, Alnujaidi OA, El Sanea O. Combined opioid free and loco-regional anaesthesia enhances the quality of recovery in sleeve gastrectomy done under ERAS protocol: a randomized controlled trial. BMC Anesthesiol. 2022 Jan 21;22(1):29. doi: 10.1186/s12871-021-01561-w.
Other Identifiers
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OFA
Identifier Type: -
Identifier Source: org_study_id