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

NCT06970626 | Recruiting Phase 2

• 1 other identifier: 16/462
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Laparoscopic Sleeve Gastrectomy

Keywords

dexmedetomidine; Laparoscopic Sleeve Gastrectomy (LSG); Paragastric Neural Block; Laparoscopic TAP

Outcome Measures

Primary Outcomes (2)

• Opioid Consumption

  Total opioids consumed by the patient will be recorded

  Opioid consumption will be measured at 4, 8, and 12 hours postoperatively

• Patient satisfaction using the QoR 40 questionnaire

  Patient satisfaction with the procedure done will be measured using the QoR (quality of recovery)40 questionnaire. Scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)

  Postoperative day 1

Secondary Outcomes (5)

• Heart Rate

  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

  Postoperative day 1

• Incidence of nausea and vomiting

  Postoperative day 1

• Baseline demographics

  preoperatively

• Blood Pressure

  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.

Study Arms (2)

Group D

ACTIVE COMPARATOR

This group (Group D) 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 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 the procedure.

Drug: Dexmedetomidine infusion; Procedure: Paragastric neural block

Group P

ACTIVE COMPARATOR

This group (Group P) will receive Paragastric neural block (PGNB) with laparoscopic TAP block (LTAP). 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. 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 the procedure.

Procedure: Paragastric neural block; Procedure: Laparoscopic Transversus Abdominis Plane (LTAP) block

Interventions

Dexmedetomidine infusion DRUG

Dexmedetomidine will be maintained at 0.5 μg/kg/h ideal body weight via a syringe pump until trocar removal.

Group D

Paragastric neural block PROCEDURE

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 the procedure.

Group D; Group P

Laparoscopic Transversus Abdominis Plane (LTAP) block PROCEDURE

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

Group P

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Main University Hospital

Alexandria, Egypt

RECRUITING

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Mai A El-Sayed, Lecturer of Anesthesia

CONTACT

00201287459922; m_mohamed165@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 14, 2025
• Study Start: April 3, 2025
• Primary Completion: June 4, 2025
• Study Completion: June 20, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)