Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

Phase 4

Completed

• Conditions: Obesity; Postoperative Pain; Postoperative Nausea; Postoperative Vomiting; Opioid Use
• Interventions: Drug: Remifentanil [Ultiva]; Drug: Dexmedetomidine Hydrochloride [Dexdor]; Drug: Ketamine [Ketalar]; Drug: Lidocaine [Xylocaine 2%]; Drug: Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]; Drug: Fentanyl [Fentanyl WZF]

• Registration Number: NCT04260659
• Lead Sponsor: Medical University of Warsaw

Brief Summary

Opioid free anesthesia is an anesthetic technique, in which administration of multimodal analgesia and sympathicolytics provides hemodynamic stability without use of opioids. Such management may be beneficial to the obese patients undergoing laparoscopic sleeve gastrectomy. Our study aims to compare opioid free anesthesia in such patients with standard, short-acting opioid based.

Detailed Description

The study has been approved by Bioethical Committee of Medical University of Warsaw. Informed written consent will be obtained from all patients. Sample size of 60 patients has been calculated based on the Altman normogram to obtain 30% reduction of postoperative opioid consumption with significance and power of 90%.

Consenting patients scheduled for laparoscopic sleeve gastrectomy will be randomly assigned to the computer generated list to receive opioid free or standard opioid based anesthesia.

Opioid free protocol includes administration of dexmedetomidine, lidocaine, ketamine, magnesium sulphate whereas standard group will receive remifentanil TCI Minto Model.

After the end of operation all of the patient will receive oxycodone and additional doses via PCA system for postoperative analgesia.

Study Timeline

• Study First Submitted: 2020-01-29
• Study Start: 2020-02-04
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-07
• Primary Completion: 2022-10-06
• Study Completion: 2023-02-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Sleeve gastrectomy in patients with BMI > 40 or >35 with comorbidities
• Written informed consent

Exclusion Criteria

• Patient's refusal
• Known allergies to study medication
• Inability to comprehend or participate In pain scoring scale
• Inability to use intravenous patient controlled analgesia
• Changes of operation extent during procedure
• Revisional operations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid free group	Fentanyl [Fentanyl WZF]	-
Opioid liberal group	Remifentanil [Ultiva]	-
Opioid free group	Dexmedetomidine Hydrochloride [Dexdor]	-
Opioid free group	Ketamine [Ketalar]	-
Opioid free group	Lidocaine [Xylocaine 2%]	-
Opioid free group	Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]	-

Primary Outcome Measures

Name	Time	Method
Total postoperative oxycodone consumption	Day "0"	PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes
Postoperative pain score in NRS scale	Day "1" assessed 24 hours after operation	NRS range from 0 for no pain to 10 for worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
Total ephedrine dosis	intraoperative	Ephedrine is a vasopressor used in case of hypotension to maintain mean arterial pressure \> 65 mmHg or to increase blood pressure to check surgical hemostasis
Postoperative desaturation	Day "0", assessed 1,6,12 and 24 hours after operation	SpO2 \< 94%
Patient's comfort assessed in QoR-40 formulary	7 days postoperatively	QoR-40 scale is used to measure the quality of recovery after surgery and anesthesia, it is a 40 item questionnaire that provides a score across five dimensions: patient support, comfort, emotions, physical independence, and pain. Formulary will assess first 24 hours following the operation and will be filled by the patient 7 days after operation
Postoperative nausea and vomiting	Day "0", assessed 1,6,12 and 24 hours after operation	Simplified PONV impact scale 0-6 0 - no nausea nor vomiting 6 - \>3 episodes of vomiting and nausea all of the time
Rescue fentanyl administration dosis	intraoperative	In opioid free group, rescue fentanyl dosis will be administered if hypertension \> 140/90 mmHg or tachycardia \> 120/min occurs
Highest BP	intraoperative	Highest BP during operation
Lowest BP	intraoperative	Lowest BP during operation
Highest HR	intraoperative	Highest HR during operation
Lowest HR	intraoperative	Lowest HR during operation
Postoperative sedation score	Day "0", assessed 1,6,12 and 24 hours after operation	1-6 Ramsay sedation score; 1 - agitated or restless 6 - unresponsive

Trial Locations

Locations (1)

Szpital Kliniczny Dzieciatka Jezus; 🇵🇱 Warsaw, Poland