Opioid Use Clinical Trial
Official title:
Paragastric Autonomic Neural Blockade as Part of Combined Anesthesia. Impact on Anesthetic Agents Consumption: A Randomized Clinical Trial Protocol
Verified date | May 2023 |
Source | Universidad Simón Bolívar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the effect of early autonomic blockade on the consumption of remifentanil and halogenated anesthesia in the intraoperative period during laparoscopic sleeve gastrectomy.
Status | Completed |
Enrollment | 79 |
Est. completion date | May 1, 2023 |
Est. primary completion date | April 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: -all adult patients scheduled for LSG at each participating institution. Exclusion Criteria - the inability to perform a PG-ANB because of anatomical difficulties - the need for revisional surgery - the need for concomitant hiatal hernia repair or other surgical procedures - conversion to open surgical procedures - allergies to local anesthetics or medication described in the anesthesia protocol - intraoperative complications (e.g., visceral or vascular perforations) - anesthesia-related complications requiring admission to intensive care |
Country | Name | City | State |
---|---|---|---|
Colombia | clinicas Portoazul e Iberoamerica | Barranquilla | Atlantico |
Lead Sponsor | Collaborator |
---|---|
Universidad Simón Bolívar |
Colombia,
Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative Remifentanil consumption | The amount of remifentanil administered will be calculated based on the amount of the consumed mix and reported as total mcg and mcg/kg/min. | duration of the anesthesia | |
Primary | Intraoperative consumption of the halogenated agent (sevoflurane) | The anesthetic machine will determine the administered amount of sevoflurane (Dräger Primus) which will be reported in ml/min. | duration of the anesthesia | |
Secondary | recovery from anesthesia measured by the Modified Aldrete Scale | The Modified Aldrete scale from 0 to 15 (a higher score correlates with better recovery from anesthesia) will be assessed and recorded 15 minutes and 1 hour after surgery. | one hour after surgery |
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