Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

Obesity Clinical Trial

Official title:

Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy: Clinical, Randomised Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04260659
• Other study ID #: OFA LSG
• Status: Completed
• Phase: Phase 4
• Start date: February 4, 2020
• Est. completion date: February 22, 2023

Study information

• Verified date: March 2023
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 22, 2023
• Est. primary completion date: October 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Opioid Use
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Postoperative Vomiting
• Vomiting

Intervention

Drug:
• Dexmedetomidine Hydrochloride [Dexdor]
Initial dosis of dexmedetomidine 1 mcg/kg IBW iv will be administered within 10 minutes before general anesthesia induction. Following intubation infusion of 1 mcg/kg IBW / h will be initiated and continued until the end of operation.
• Remifentanil [Ultiva]
Remifentanil TCI Minto Model will be used during induction in dosis 6 ng/ml and intraoperatively appropriately to maintain hemodynamical stability.
• Ketamine [Ketalar]
Ketamine 0,5mg/kg IBW iv will be administered during induction of general anesthesia.
• Lidocaine [Xylocaine 2%]
Initial dosis of lidocaine 1,5 mg/kg IBW iv will be administered within 10 minutes before general anesthesia induction. Following intubation infusion of 3 mg/kg IBW / h will be initiated and continued until the end of operation.
• Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]
Magnesium Sulphate will be administered in dosis 50 mg/kg IBW iv intraoperatively.
• Fentanyl [Fentanyl WZF]
Rescue dosis of 100 mcg iv will be administered if hypertension > 140/90 mmHg or tachycardia > 120min occurs. If necessary rescue dosis may be repeated.

Locations

Country	Name	City	State
Poland	Szpital Kliniczny Dzieciatka Jezus	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total postoperative oxycodone consumption	PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes	Day "0"
Primary	Postoperative pain score in NRS scale	NRS range from 0 for no pain to 10 for worst pain imaginable	Day "0", assessed 1 hour after operation
Primary	Postoperative pain score in NRS scale	NRS range from 0 for no pain to 10 for worst pain imaginable	Day "0", assessed 6 hours after operation
Primary	Postoperative pain score in NRS scale	NRS range from 0 for no pain to 10 for worst pain imaginable	Day "0", assessed 12 hours after operation
Primary	Postoperative pain score in NRS scale	NRS range from 0 for no pain to 10 for worst pain imaginable	Day "1" assessed 24 hours after operation
Secondary	Postoperative sedation score	1-6 Ramsay sedation score; 1 - agitated or restless 6 - unresponsive	Day "0", assessed 1,6,12 and 24 hours after operation
Secondary	Postoperative nausea and vomiting	Simplified PONV impact scale 0-6 0 - no nausea nor vomiting 6 - >3 episodes of vomiting and nausea all of the time	Day "0", assessed 1,6,12 and 24 hours after operation
Secondary	Rescue fentanyl administration dosis	In opioid free group, rescue fentanyl dosis will be administered if hypertension > 140/90 mmHg or tachycardia > 120/min occurs	intraoperative
Secondary	Highest BP	Highest BP during operation	intraoperative
Secondary	Lowest BP	Lowest BP during operation	intraoperative
Secondary	Highest HR	Highest HR during operation	intraoperative
Secondary	Lowest HR	Lowest HR during operation	intraoperative
Secondary	Total ephedrine dosis	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	intraoperative
Secondary	Postoperative desaturation	SpO2 < 94%	Day "0", assessed 1,6,12 and 24 hours after operation
Secondary	Patient's comfort assessed in QoR-40 formulary	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	7 days postoperatively