Laparoscopic Sleeve Gastrectomy (LSG)Phase 1/2NCT06970678
Combining Dexmedetomidine Infusion and Paragastric Autonomic Neural Block to Enhance Postoperative Recovery in Patients Undergoing Laparoscopic Sleeve Gastrectomy
A Phase 1/2 study testing Dexmedetomidine infusion and paragastric autonomic neural block in people with Laparoscopic Sleeve Gastrectomy (LSG), run by Alexandria University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if combining Dexmedetomidine infusion and paragastric autonomic neural block will enhance the postoperative recovery of patients undergoing laparoscopic sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laparoscopic Sleeve Gastrectomy (LSG)
- What is being tested?
- Dexmedetomidine infusion and paragastric autonomic neural block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Apr 2025to 18 Jun 2025
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA II-III
- 18-60 years
- BMI of 35-50 kg/m²
Who cannot join
- Patients with chronic pain disorders
- Patients using gabapentin, chronic opioid users
- Patients on anticoagulant therapy
- Patients with history of upper gastrointestinal system surgery
- Patients with liver, kidney, cardiovascular diseases
- Patients with allergy 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
Official title: Efficacy of Dexmedetomidine Infusion Combined With Paragastric Neural Block in Enhancing Postoperative Recovery Following Laparoscopic Sleeve Gastrectomy
The goal of this clinical trial is to learn if combining Dexmedetomidine infusion and paragastric autonomic neural block will enhance the postoperative recovery of patients undergoing laparoscopic sleeve gastrectomy. The main questions it aims to answer are:
Will combining the two techniques (Dexmedetomidine infusion and paragastric autonomic neural block) improve the quality of recovery? Will opioid consumption postoperatively decrease after combining those two techniques? Will the patients be able to start mobilizing sooner after surgery? Will the patient encounter less incidence of nausea and vomiting?
Researchers will asses the quality of the patients' recovery by reviewing the Quality of recovery 40 (QoR 40) questionnaire filled by the patients, assessing hemodynamic parameters intra- and postoperatively, recording the opioids consumed by the patients in the postoperative period, recording the time to first mobilization of the patient, and recording the incidence of nausea and vomiting.
- Conditions
- Laparoscopic Sleeve Gastrectomy (LSG)
- Being tested
- Dexmedetomidine infusion, paragastric autonomic neural block
- Keywords
- dexmedetomidine infusion, laparoscopic sleeve gastrectomy (LSG), paragastric neural block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine infusionDrug
Patients 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 autonomic neural blockProcedure or surgery
Paragastric autonomic neural block (PGANB) 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, esophagogastric junction, proximal stomach, mid-stomach, distal antrum, hepatic artery, and left gastric artery, with the needle cap removed under direct vision throughout the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving Dexmedetomidine infusion plus PGANB | Experimental | Patients 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 autonomic neural block (PGANB) 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, esophagogastric 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 autonomic neural block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patient satisfaction will be measured using the QoR 40 questionnaire, filled by the patients (ranging from 40, which is extremely poor quality of recovery to 200, which is excellent quality of recovery)
Measured: Postoperative day 1
Secondary outcomes (6)
Baseline Demographics
Age, sex, body mass index (BMI), comorbidities will be recorded
Measured: preoperative
Heart Rate
heart rate (beats/min) will be monitored continuously every 5 minutes and recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours, and 12 hours postoperatively.
Measured: Heart rate will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.
Blood Pressure
blood pressure (mmHg) will be monitored continuously every 5 minutes and recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours, and 12 hours postoperatively.
Measured: Blood pressure will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours, and 12 hours postoperatively.
Opioid consumption
Total opioids consumed by the patients will be recorded at 4, 8, 12 hours postoperative
Measured: at 4, 8, 12 hours postoperative
Time to mobilize
The time to first mobilization (in minutes) of the patient will be recorded
Measured: Immediately postoperatively (in minutes)
Incidence of nausea and vomiting
The incidence of nausea and vomiting postoperatively will be recorded
Measured: Postoperative day 1
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 start4 Apr 2025
- Primary completion6 Jun 2025 (estimated)
- Study completion18 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 Gastrectomy (LSG)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 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
- NCT06970678
- Sponsor's protocol ID
- 16/463
- 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
- Efficacy of Dexmedetomidine Infusion Combined With Paragastric Neural Block in Enhancing Postoperative Recovery Following Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT06970678
- Acronym / sponsor ID
- 16/463
- Conditions
- Laparoscopic Sleeve Gastrectomy (LSG)
- Keywords
- dexmedetomidine infusion, laparoscopic sleeve gastrectomy (LSG), paragastric neural block
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 6 Jun 2025 (estimated)
- Study completion
- 18 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 if combining Dexmedetomidine infusion and paragastric autonomic neural block will enhance the postoperative recovery of patients undergoing laparoscopic sleeve gastrectomy. The main questions it aims to answer are:
Will combining the two techniques (Dexmedetomidine infusion and paragastric autonomic neural block) improve the quality of recovery? Will opioid consumption postoperatively decrease after combining those two techniques? Will the patients be able to start mobilizing sooner after surgery? Will the patient encounter less incidence of nausea and vomiting?
Researchers will asses the quality of the patients' recovery by reviewing the Quality of recovery 40 (QoR 40) questionnaire filled by the patients, assessing hemodynamic parameters intra- and postoperatively, recording the opioids consumed by the patients in the postoperative period, recording the time to first mobilization of the patient, and recording the incidence of nausea and vomiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Dexmedetomidine infusion plus PGANB | Experimental | Drug: Dexmedetomidine infusion, Procedure: paragastric autonomic neural blockPatients 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 autonomic neural block (PGANB) 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, esophagogastric 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
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA II-III
- 18-60 years
- BMI of 35-50 kg/m²
Key exclusion criteria (6 listed)
- Patients with chronic pain disorders
- Patients using gabapentin, chronic opioid users
- Patients on anticoagulant therapy
- Patients with history of upper gastrointestinal system surgery
- Patients with liver, kidney, cardiovascular diseases
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 infusionPatients 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. | Drug | Patients receiving Dexmedetomidine infusion plus PGANB |
| paragastric autonomic neural blockParagastric autonomic neural block (PGANB) 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, esophagogastric 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 | Patients receiving Dexmedetomidine infusion plus PGANB |
Primary outcome
Patient Satisfaction
Time frame: Postoperative day 1
Patient satisfaction will be measured using the QoR 40 questionnaire, filled by the patients (ranging from 40, which is extremely poor quality of recovery to 200, which is excellent quality of recovery)
6 secondary outcomes
Baseline Demographics
Time frame: preoperative
Heart Rate
Time frame: Heart rate will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.
Blood Pressure
Time frame: Blood pressure will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours, and 12 hours postoperatively.
Opioid consumption
Time frame: at 4, 8, 12 hours postoperative
Time to mobilize
Time frame: Immediately postoperatively (in minutes)
Incidence of nausea and vomiting
Time frame: Postoperative day 1
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 1/2 study testing Dexmedetomidine infusion and paragastric autonomic neural block in people with Laparoscopic Sleeve Gastrectomy (LSG), 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 3 inclusion and 6 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Patient Satisfaction (time frame: Postoperative day 1). 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.