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NCT Number: NCT06970678

Combining Dexmedetomidine Infusion and Paragastric Autonomic Neural Block to Enhance Postoperative Recovery in Patients Undergoing 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.

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Key information

Conditions

Laparoscopic Sleeve Gastrectomy (LSG)

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Alexandria Main University Hospital

Alexandria, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Baseline Demographics

    Time frame: preoperative

    Age, sex, body mass index (BMI), comorbidities will be recorded

  2. 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.

    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.

  3. 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.

    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.

  4. Opioid consumption

    Time frame: at 4, 8, 12 hours postoperative

    Total opioids consumed by the patients will be recorded at 4, 8, 12 hours postoperative

  5. Time to mobilize

    Time frame: Immediately postoperatively (in minutes)

    The time to first mobilization (in minutes) of the patient will be recorded

  6. Incidence of nausea and vomiting

    Time frame: Postoperative day 1

    The incidence of nausea and vomiting postoperatively will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Mai A El-Sayed, Lecturer of Anesthesia

CONTACT

[email protected]

00201287459922

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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