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Recruiting NCT06970678

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

Phase I / Phase II Interventional Laparoscopic Sleeve Gastrectomy (LSG)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine infusion, paragastric autonomic neural block.
Who it may be relevant to
Registry conditions: Laparoscopic Sleeve Gastrectomy (LSG). Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Efficacy of Dexmedetomidine Infusion Combined With Paragastric Neural Block in Enhancing Postoperative Recovery Following Laparoscopic Sleeve Gastrectomy

Overview

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.

Interventions

  • Drug Dexmedetomidine infusion
    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.
  • Procedure paragastric autonomic neural block
    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 t

Primary outcome measures

  • Patient Satisfaction [Time frame: Postoperative day 1]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • ASA II-III
  • 18-60 years
  • BMI of 35-50 kg/m²

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Alexandria Main University Hospital — Alexandria

Identifiers

NCT: NCT06970678 · 16/463

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗