Quality of Recovery in Laparoscopic Sleeve Gastrectomy Using Dexmedetomidine Infusion Versus Laparoscopic TAP Block in Combination With Paragastric Neural Block

Обзор

The goal of this clinical trial is to learn which is better, combining Dexmedetomidine infusion and paragastric neural block or combining laparoscopic TAP block and paragastric neural block to enhance recovery after laparoscopic sleeve gastrectomy. The main questions it aims to answer are: Will using paragastric neural block (PGNB) combined with dexmedetomidine infusion give better recovery or using PGNB combined with laparoscopic transversus abdominis plane (LTAP) block in patients undergoing laparoscopic sleeve gastrectomy. This will be assessed by: Recording how much opioids were consumed by the patients Hemodynamic stability of the enrolled patients Pain scores as given by the patient The quality of postoperative patient recovery How many patients encountered nausea or vomiting

Вмешательства

• Препарат Dexmedetomidine infusion
  Dexmedetomidine will be maintained at 0.5 μg/kg/h ideal body weight via a syringe pump until trocar removal.
• Процедура Paragastric neural block
  Paragastric neural block (PGNB) 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, esophago-gastric junction, proximal stomach, mid-stomach, distal antrum, hepatic artery, and left gastric artery, with the needle cap removed under direct vision throughout
• Процедура Laparoscopic Transversus Abdominis Plane (LTAP) block
  LTAP will be administered after insufflation before insertion of the right and left-handed ports. 30 mL of 0.25% bupivacaine will be injected into the posterolateral subcostal regions on both sides. The correct placement will be confirmed by observing the spread of fluid between the transversus abdominis and the internal oblique muscle layers laparoscopically

Первичные конечные точки

• Opioid Consumption [Срок оценки: Opioid consumption will be measured at 4, 8, and 12 hours postoperatively]
• Patient satisfaction using the QoR 40 questionnaire [Срок оценки: Postoperative day 1]

Вторичные конечные точки (5)

• Heart Rate [Срок оценки: Heart rate will be monitored continuously every 5 minutes and will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.]
• Time to mobilize [Срок оценки: Postoperative day 1]
• Incidence of nausea and vomiting [Срок оценки: Postoperative day 1]
• Baseline demographics [Срок оценки: preoperatively]
• Blood Pressure [Срок оценки: Blood pressure will be monitored continuously every 5 minutes and will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.]

Критерии участия

Критерии включения

• American Society of Anesthesiologists (ASA) physical status II- III
• BMI 35- 50 kg/m2

Критерии исключения

• Significant hepatic, renal, neuromuscular, or cardiac impairments
• Extreme obesity (BMI > 50 kg/m2)
• Patients on current opioid medication
• Allergies to dexmedetomidine or bupivacaine

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Alexandria Main University Hospital — Alexandria

Идентификаторы

NCT: NCT06970626 · 16/462

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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