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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Процедура 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

Первичные конечные точки

• Patient Satisfaction [Срок оценки: Postoperative day 1]

Вторичные конечные точки (6)

• Baseline Demographics [Срок оценки: preoperative]
• Heart Rate [Срок оценки: Heart rate will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.]
• Blood Pressure [Срок оценки: Blood pressure will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours, and 12 hours postoperatively.]
• Opioid consumption [Срок оценки: at 4, 8, 12 hours postoperative]
• Time to mobilize [Срок оценки: Immediately postoperatively (in minutes)]
• Incidence of nausea and vomiting [Срок оценки: Postoperative day 1]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Alexandria Main University Hospital — Alexandria

Идентификаторы

NCT: NCT06970678 · 16/463

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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