Laparoscopic Sleeve GastrectomyPhase 2/3NCT06970626
Quality of Recovery in Laparoscopic Sleeve Gastrectomy Using Dexmedetomidine Infusion Versus Laparoscopic TAP Block in Combination With Paragastric Neural Block
A Phase 2/3 study testing Dexmedetomidine infusion, Paragastric neural block and Laparoscopic Transversus Abdominis Plane (LTAP) block in people with Laparoscopic Sleeve Gastrectomy, run by Alexandria University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn which is better, combining Dexmedetomidine infusion and paragastric neural block or combining laparoscopic TAP block and paragastric neural block to enhance recovery after laparoscopic sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Laparoscopic Sleeve Gastrectomy
- What is being tested?
- Dexmedetomidine infusion, Paragastric neural block and Laparoscopic Transversus Abdominis Plane (LTAP) block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2025to 20 Jun 2025
- Phase
- Phase 2/3
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status II- III
- BMI 35- 50 kg/m2
Who cannot join
- Significant hepatic, renal, neuromuscular, or cardiac impairments
- Extreme obesity (BMI > 50 kg/m2)
- Patients on current opioid medication
- Allergies to dexmedetomidine or bupivacaine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Main University Hospital
Alexandria
About this study
The goal of this clinical trial is to learn which is better, combining Dexmedetomidine infusion and paragastric neural block or combining laparoscopic TAP block and paragastric neural block to enhance recovery after laparoscopic sleeve gastrectomy.
The main questions it aims to answer are:
Read more
Will using paragastric neural block (PGNB) combined with dexmedetomidine infusion give better recovery or using PGNB combined with laparoscopic transversus abdominis plane (LTAP) block in patients undergoing laparoscopic sleeve gastrectomy.
This will be assessed by:
Recording how much opioids were consumed by the patients Hemodynamic stability of the enrolled patients Pain scores as given by the patient The quality of postoperative patient recovery How many patients encountered nausea or vomiting
- Conditions
- Laparoscopic Sleeve Gastrectomy
- Being tested
- Dexmedetomidine infusion, Paragastric neural block, Laparoscopic Transversus Abdominis Plane (LTAP) block
- Keywords
- dexmedetomidine, Laparoscopic Sleeve Gastrectomy (LSG), Paragastric Neural Block, Laparoscopic TAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine infusionDrug
Dexmedetomidine will be maintained at 0.5 μg/kg/h ideal body weight via a syringe pump until trocar removal.
Paragastric neural blockProcedure or surgery
Paragastric neural block (PGNB) will be administered using a 25-gauge needle attached to a venous catheter extension, introduced through the left 12 mm port. Infiltration of 20 mL undiluted 0.5% bupivacaine will be performed at six levels in the fatty tissue of the paragastric area, including the lesser omentum, vagus nerve, esophago-gastric junction, proximal stomach, mid-stomach, distal antrum, hepatic artery, and left gastric artery, with the needle cap removed under direct vision throughout the procedure.
Laparoscopic Transversus Abdominis Plane (LTAP) blockProcedure or surgery
LTAP will be administered after insufflation before insertion of the right and left-handed ports. 30 mL of 0.25% bupivacaine will be injected into the posterolateral subcostal regions on both sides. The correct placement will be confirmed by observing the spread of fluid between the transversus abdominis and the internal oblique muscle layers laparoscopically
| Study group | Role | What they receive |
|---|---|---|
| Group D | Active comparator | This group (Group D) will receive intravenous loading dose of dexmedetomidine at 0.5 μg/kg ideal body weight (concentration 2 μg/ml) over 15 minutes prior to anesthesia induction, followed by 10 ml of 0.9% sodium chloride over 60 seconds during anesthetic induction. Post-intubation, Dexmedetomidine will be maintained at 0.5 μg/kg/h ideal body weight via a syringe pump until trocar removal. Paragastric neural block (PGNB) will be administered using a 25-gauge needle attached to a venous catheter extension, introduced through the left 12 mm port. Infiltration of 20 mL undiluted 0.5% bupivacaine will be performed at six levels in the fatty tissue of the paragastric area, including the lesser omentum, vagus nerve, esophago-gastric junction, proximal stomach, mid-stomach, distal antrum, hepatic artery, and left gastric artery, with the needle cap removed under direct vision throughout the procedure. Receives: Drug: Dexmedetomidine infusion; Procedure: Paragastric neural block |
| Group P | Active comparator | This group (Group P) will receive Paragastric neural block (PGNB) with laparoscopic TAP block (LTAP). LTAP will be administered after insufflation before insertion of the right and left-handed ports. 30 mL of 0.25% bupivacaine will be injected into the posterolateral subcostal regions on both sides. The correct placement will be confirmed by observing the spread of fluid between the transversus abdominis and the internal oblique muscle layers laparoscopically. Paragastric neural block (PGNB) will be administered using a 25-gauge needle attached to a venous catheter extension, introduced through the left 12 mm port. Infiltration of 20 mL undiluted 0.5% bupivacaine will be performed at six levels in the fatty tissue of the paragastric area, including the lesser omentum, vagus nerve, esophago-gastric junction, proximal stomach, mid-stomach, distal antrum, hepatic artery, and left gastric artery, with the needle cap removed under direct vision throughout the procedure. Receives: Procedure: Paragastric neural block; Procedure: Laparoscopic Transversus Abdominis Plane (LTAP) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Total opioids consumed by the patient will be recorded
Measured: Opioid consumption will be measured at 4, 8, and 12 hours postoperatively
Patient satisfaction using the QoR 40 questionnaire
Patient satisfaction with the procedure done will be measured using the QoR (quality of recovery)40 questionnaire. Scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)
Measured: Postoperative day 1
Secondary outcomes (5)
Heart Rate
Heart rate (beats/min) will be monitored continuously every 5 minutes and will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.
Measured: Heart rate will be monitored continuously every 5 minutes and will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.
Time to mobilize
The time to which the patient will be able to start mobilization after surgery will be recorded (in minutes)
Measured: Postoperative day 1
Incidence of nausea and vomiting
The incidence of nausea and vomiting after surgery will be recorded
Measured: Postoperative day 1
Baseline demographics
Age, sex, body mass index (BMI), and comorbidities will be recorded
Measured: preoperatively
Blood Pressure
Blood pressure (mmHg) will be monitored continuously every 5 minutes and will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.
Measured: Blood pressure will be monitored continuously every 5 minutes and will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start3 Apr 2025
- Primary completion4 Jun 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Sleeve GastrectomyStudies of the same condition, open and under way.
- More trials run by Alexandria 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970626
- Sponsor's protocol ID
- 16/462
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery in Laparoscopic Sleeve Gastrectomy Using Dexmedetomidine Infusion Versus Laparoscopic TAP Block in Combination With Paragastric Neural Block
- ClinicalTrials.gov ID
- NCT06970626
- Acronym / sponsor ID
- 16/462
- Conditions
- Laparoscopic Sleeve Gastrectomy
- Keywords
- dexmedetomidine, Laparoscopic Sleeve Gastrectomy (LSG), Paragastric Neural Block, Laparoscopic TAP
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 4 Jun 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 14 May 2025 (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.
The goal of this clinical trial is to learn which is better, combining Dexmedetomidine infusion and paragastric neural block or combining laparoscopic TAP block and paragastric neural block to enhance recovery after laparoscopic sleeve gastrectomy.
The main questions it aims to answer are:
Will using paragastric neural block (PGNB) combined with dexmedetomidine infusion give better recovery or using PGNB combined with laparoscopic transversus abdominis plane (LTAP) block in patients undergoing laparoscopic sleeve gastrectomy.
This will be assessed by:
Recording how much opioids were consumed by the patients Hemodynamic stability of the enrolled patients Pain scores as given by the patient The quality of postoperative patient recovery How many patients encountered nausea or vomiting
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | Active comparator | Drug: Dexmedetomidine infusion, Procedure: Paragastric neural blockThis group (Group D) will receive intravenous loading dose of dexmedetomidine at 0.5 μg/kg ideal body weight (concentration 2 μg/ml) over 15 minutes prior to anesthesia induction, followed by 10 ml of 0.9% sodium chloride over 60 seconds during anesthetic induction. Post-intubation, Dexmedetomidine will be maintained at 0.5 μg/kg/h ideal body weight via a syringe pump until trocar removal. Paragastric neural block (PGNB) will be administered using a 25-gauge needle attached to a venous catheter extension, introduced through the left 12 mm port. Infiltration of 20 mL undiluted 0.5% bupivacaine will be performed at six levels in the fatty tissue of the paragastric area, including the lesser omentum, vagus nerve, esophago-gastric junction, proximal stomach, mid-stomach, distal antrum, hepatic artery, and left gastric artery, with the needle cap removed under direct vision throughout the procedure. |
| Group P | Active comparator | Procedure: Paragastric neural block, Procedure: Laparoscopic Transversus Abdominis Plane (LTAP) blockThis group (Group P) will receive Paragastric neural block (PGNB) with laparoscopic TAP block (LTAP). LTAP will be administered after insufflation before insertion of the right and left-handed ports. 30 mL of 0.25% bupivacaine will be injected into the posterolateral subcostal regions on both sides. The correct placement will be confirmed by observing the spread of fluid between the transversus abdominis and the internal oblique muscle layers laparoscopically. Paragastric neural block (PGNB) will be administered using a 25-gauge needle attached to a venous catheter extension, introduced through the left 12 mm port. Infiltration of 20 mL undiluted 0.5% bupivacaine will be performed at six levels in the fatty tissue of the paragastric area, including the lesser omentum, vagus nerve, esophago-gastric junction, proximal stomach, mid-stomach, distal antrum, hepatic artery, and left gastric artery, with the needle cap removed under direct vision throughout the procedure. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status II- III
- BMI 35- 50 kg/m2
Key exclusion criteria (4 listed)
- Significant hepatic, renal, neuromuscular, or cardiac impairments
- Extreme obesity (BMI > 50 kg/m2)
- Patients on current opioid medication
- Allergies to dexmedetomidine or bupivacaine
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 |
|---|---|---|
| Dexmedetomidine infusionDexmedetomidine will be maintained at 0.5 μg/kg/h ideal body weight via a syringe pump until trocar removal. | Drug | Group D |
| Paragastric neural blockParagastric neural block (PGNB) will be administered using a 25-gauge needle attached to a venous catheter extension, introduced through the left 12 mm port. Infiltration of 20 mL undiluted 0.5% bupivacaine will be performed at six levels in the fatty tissue of the paragastric area, including the lesser omentum, vagus nerve, esophago-gastric junction, proximal stomach, mid-stomach, distal antrum, hepatic artery, and left gastric artery, with the needle cap removed under direct vision throughout the procedure. | Procedure or surgery | Group D, Group P |
| Laparoscopic Transversus Abdominis Plane (LTAP) blockLTAP will be administered after insufflation before insertion of the right and left-handed ports. 30 mL of 0.25% bupivacaine will be injected into the posterolateral subcostal regions on both sides. The correct placement will be confirmed by observing the spread of fluid between the transversus abdominis and the internal oblique muscle layers laparoscopically | Procedure or surgery | Group P |
Primary outcome
Opioid Consumption
Time frame: Opioid consumption will be measured at 4, 8, and 12 hours postoperatively
Total opioids consumed by the patient will be recorded
Patient satisfaction using the QoR 40 questionnaire
Time frame: Postoperative day 1
Patient satisfaction with the procedure done will be measured using the QoR (quality of recovery)40 questionnaire. Scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)
5 secondary outcomes
Heart Rate
Time frame: Heart rate will be monitored continuously every 5 minutes and will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.
Time to mobilize
Time frame: Postoperative day 1
Incidence of nausea and vomiting
Time frame: Postoperative day 1
Baseline demographics
Time frame: preoperatively
Blood Pressure
Time frame: Blood pressure will be monitored continuously every 5 minutes and will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.
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 14 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine infusion, Paragastric neural block and Laparoscopic Transversus Abdominis Plane (LTAP) block in people with Laparoscopic Sleeve Gastrectomy, run by Alexandria 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 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: looking for participants now, as of the sponsor's last update on 14 May 2025. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mai A El-Sayed, Lecturer of Anesthesia (00201287459922, m_mohamed165@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption (time frame: Opioid consumption will be measured at 4, 8, and 12 hours postoperatively). 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 14 May 2025.