NarcoticsNCT04285255
Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy
A study testing Fentanyl, Ketamine and Dexmedetomidine Injection [Precedex] in people with Narcotics and Recovery Quality, run by Al Mashfa Medical Center at 1 site in Saudi Arabia.
Trial summary
Laparoscopic sleeve gastrectomy is widely employed nowadays. Multimodal analgesia approach is implemented within the enhanced recovery protocol in our facility to improve participants' recovery. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Narcotics, Recovery Quality, Analgesia
- What is being tested?
- Fentanyl, Ketamine and Dexmedetomidine Injection [Precedex]
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Mar 2020to 1 Aug 2020
- Phase
- Interventional
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 70 ASA II - III adult patients (18-60 years old)
- Elective laparoscopic bariatric surgery.
- Body mass index (BMI) is from 40 to 60
- Trocar sites at or above the umbilicus (T 10 dermatome).
Who cannot join
- Allergy to amino-amide local anaesthetics,
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Al Mashfa medical center
Khobar, Eastern Provence, 34225/7564
About this study
Official title: Quality of Recovery of Opioid Free Anaesthesia Versus Opioids Anaesthesia Within Enhanced Recovery Protocol Following Laparoscopic Sleeve Gastrectomy in Saudi Arabia, Randomized Controlled Trial
Laparoscopic sleeve gastrectomy is widely employed nowadays. Multimodal analgesia approach is implemented within the enhanced recovery protocol in our facility to improve participants' recovery. Due to side effects of narcotics, the may adversely affect the quality of recovery, the investigators intended to test the efficacy of opioids free anaesthesia on the quality of recovery and postoperative narcotic use.
- Conditions
- Narcotics, Recovery Quality, Analgesia, Bariatric Surgery
- Being tested
- Fentanyl, Ketamine, Dexmedetomidine Injection [Precedex], Oblique subcostal transversus abdominis plane block, Lidocaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
opioids anaesthesia
KetamineDrug
ketamine induction and analgesia as opioids free anaesthesia versus opioids analgesia
Dexmedetomidine Injection [Precedex]Drug
alpha 2 agonist with sedative, analgesic effect
Oblique subcostal transversus abdominis plane blockProcedure or surgery
Bupivacaine 0.25% injected under ultrasound usage in the transversus abdominis plane
LidocaineDrug
infusion of lidocaine 2%(1mg/kg/h)
| Study group | Role | What they receive |
|---|---|---|
| Opioids anesthesia | Active comparator | 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 Receives: Drug: Fentanyl; Procedure: Oblique subcostal transversus abdominis plane block |
| OFA | Active comparator | 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 Receives: Drug: Ketamine; Drug: Dexmedetomidine Injection [Precedex]; Procedure: Oblique subcostal transversus abdominis plane block; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery 40 questionnaire (QoR-40)
postoperative quality of recovery
Measured: At 6 hours
Quality of recovery 40 questionnaire (QoR-40)
postoperative quality of recovery
Measured: At 24th h (period of time between 6 and 24 hours) as repeated measurement
Secondary outcomes (2)
Pethidine consumption
Measured: 24 hours
Numerical rating scale (NRS)
visual analogue scale postoperatively
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 Mar 2020
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NarcoticsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al Mashfa Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285255
- Sponsor's protocol ID
- OFA
- Status last verified
- Mar 2020
- First submitted
- 22 Feb 2020
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35062872
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery of Opioid Free Anaesthesia Versus Opioids Anaesthesia Within Enhanced Recovery Protocol Following Laparoscopic Sleeve Gastrectomy in Saudi Arabia, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04285255
- Acronym / sponsor ID
- OFA
- Conditions
- Narcotics, Recovery Quality, Analgesia, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Al Mashfa Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 26 Feb 2020 (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.
Laparoscopic sleeve gastrectomy is widely employed nowadays. Multimodal analgesia approach is implemented within the enhanced recovery protocol in our facility to improve participants' recovery. Due to side effects of narcotics, the may adversely affect the quality of recovery, the investigators intended to test the efficacy of opioids free anaesthesia on the quality of recovery and postoperative narcotic use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioids anesthesia | Active comparator | Drug: Fentanyl, Procedure: Oblique subcostal transversus abdominis plane blockreceived 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 |
| OFA | Active comparator | Drug: Ketamine, Drug: Dexmedetomidine Injection [Precedex], Procedure: Oblique subcostal transversus abdominis plane block, Drug: Lidocainereceived 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 70 ASA II - III adult patients (18-60 years old)
- Elective laparoscopic bariatric surgery.
- Body mass index (BMI) is from 40 to 60
- Trocar sites at or above the umbilicus (T 10 dermatome).
Key exclusion criteria (9 listed)
- Allergy to amino-amide local anaesthetics,
- presence of coagulopathy
- local skin infection at injection sites,
- preoperative chronic dependence upon opioid and NSAID medications,
- liver or renal insufficiency,
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 |
|---|---|---|
| Fentanylopioids anaesthesia | Drug | Opioids anesthesia |
| Ketamineketamine induction and analgesia as opioids free anaesthesia versus opioids analgesia | Drug | OFA |
| Dexmedetomidine Injection [Precedex]alpha 2 agonist with sedative, analgesic effect | Drug | OFA |
| Oblique subcostal transversus abdominis plane blockBupivacaine 0.25% injected under ultrasound usage in the transversus abdominis plane | Procedure or surgery | OFA, Opioids anesthesia |
| Lidocaineinfusion of lidocaine 2%(1mg/kg/h) | Drug | OFA |
Primary outcome
Quality of recovery 40 questionnaire (QoR-40)
Time frame: At 6 hours
postoperative quality of recovery
Quality of recovery 40 questionnaire (QoR-40)
Time frame: At 24th h (period of time between 6 and 24 hours) as repeated measurement
postoperative quality of recovery
2 secondary outcomes
Pethidine consumption
Time frame: 24 hours
Numerical rating scale (NRS)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Derived from this study: PubMed 35062872Ibrahim 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl, Ketamine and Dexmedetomidine Injection [Precedex] in people with Narcotics and Recovery Quality, run by Al Mashfa Medical Center at 1 site in Saudi Arabia.
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 9 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: finished, as of the sponsor's last update on 8 Nov 2021. 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 Saudi Arabia. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery 40 questionnaire (QoR-40) (time frame: At 6 hours). 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?
On the ClinicalTrials.gov record for NCT04285255, which also lists 1 linked publication.
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 8 Nov 2021.