Combining Dexmedetomidine Infusion and Paragastric Autonomic Neural Block to Enhance Postoperative Recovery in Patients Undergoing Laparoscopic Sleeve Gastrectomy

NCT06970678 | Recruiting Phase 1

• 1 other identifier: 16/463
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

dexmedetomidine infusion; laparoscopic sleeve gastrectomy (LSG); paragastric neural block

Outcome Measures

Primary Outcomes (1)

• 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)

  Postoperative day 1

Secondary Outcomes (6)

• Baseline Demographics

  preoperative

• Heart Rate

  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 will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours, and 12 hours postoperatively.

• Opioid consumption

  at 4, 8, 12 hours postoperative

• Time to mobilize

  Immediately postoperatively (in minutes)

Study Arms (1)

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.

Drug: Dexmedetomidine infusion; Procedure: paragastric autonomic neural block

Interventions

Dexmedetomidine infusion DRUG

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.

Patients receiving Dexmedetomidine infusion plus PGANB

paragastric autonomic neural block PROCEDURE

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.

Patients receiving Dexmedetomidine infusion plus PGANB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA II-III
• years
• BMI of 35-50 kg/m²

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Main University Hospital

Alexandria, Egypt

RECRUITING

Central Study Contacts

Mai A El-Sayed, Lecturer of Anesthesia

CONTACT

00201287459922; m_mohamed165@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 14, 2025
• Study Start: April 4, 2025
• Primary Completion: June 6, 2025
• Study Completion: June 18, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)