Laparoscopic Sleeve Gastrectomy
Conditions
Keywords
dexmedetomidine, Laparoscopic Sleeve Gastrectomy (LSG), Paragastric Neural Block, Laparoscopic TAP
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
Interventions
DRUGDexmedetomidine infusion
Dexmedetomidine will be maintained at 0.5 μg/kg/h ideal body weight via a syringe pump until trocar removal.
PROCEDUREParagastric 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 the procedure.
PROCEDURELaparoscopic 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
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. American Society of Anesthesiologists (ASA) physical status II- III 2. BMI 35- 50 kg/m2
Exclusion criteria
1. Significant hepatic, renal, neuromuscular, or cardiac impairments 2. Extreme obesity (BMI \> 50 kg/m2) 3. Patients on current opioid medication 4. Allergies to dexmedetomidine or bupivacaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | Opioid consumption will be measured at 4, 8, and 12 hours postoperatively | Total opioids consumed by the patient will be recorded |
| Patient satisfaction using the QoR 40 questionnaire | Postoperative day 1 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of nausea and vomiting | Postoperative day 1 | The incidence of nausea and vomiting after surgery will be recorded |
| 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. | Heart rate (beats/min) 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. |
| 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. | Blood pressure (mmHg) 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. |
| Baseline demographics | preoperatively | Age, sex, body mass index (BMI), and comorbidities will be recorded |
| Time to mobilize | Postoperative day 1 | The time to which the patient will be able to start mobilization after surgery will be recorded (in minutes) |
Countries
Egypt
Contacts
Primary ContactMai A El-Sayed, Lecturer of Anesthesia
Outcome results
None listed