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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05591105
Other study ID # TIVA OFA Obese patients
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2023
Est. completion date January 31, 2024

Study information

Verified date May 2024
Source Tiva Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to evaluate the quality of postoperative analgesia in a group of obese patients schedule to bariatric surgery under TIVA Opiod-free after to receive lidocaine and ketamine perfusion. The main question it aims to answer are: How lidocaine and ketamine perfusion during recovery period does impact over morphine consumption on the following 48 hours after surgery? All participants will receive total intravenous anesthesia and, at the end of the surgery, they will be divided in two groups, group A: placebo and, group B: with postoperative lidocaine and ketamine perfusion. Our hypothesis is ketamine and lidocaine are a good alternative to decrease the use of morphine in obese patients.


Description:

The obese patients have more risk for certain side effects and complications with elevated risk of perioperative mortality and morbidity. An effective postoperative pain management is important to prevent pulmonary complications and, it is not recommended continuous infusions of opioids in this kind of patients, because the opioid-induced upper airway obstruction and respiratory depression are more likely to be seen in obese patients with obstructive sleep apnea. We can reduce perioperative opioid using dexmedetomidine, ketamine and lidocaine, however, it is a little know the use and benefits of lidocaine and ketamine inmediately after surgery.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date January 31, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - All patients between 18 y 65 years old. - IMC > 30 kg/m2 - ASA II/III Exclusion Criteria: - Patients taking high doses of opioids before operation for chronic pain - Patients with allergies to any study medication. - Pregnancy or breastfeeding. - Kidney or heptic failure. - Surgical complication

Study Design


Intervention

Drug:
Control Group
At the end of surgery, they will continue receiving analgesia according the schedule and, addicionally, lidocaine (1 mg/kg/h) and Ketamine (0,15 mg/kg/h) for 90 minute as part of postoperative analgesia.
Placebo
At the end of surgery, they will continue receiving analgesia according the schedule.

Locations

Country Name City State
Spain Carolina Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Tiva Group

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Kind of surgery The laparoscopic Sleeve Gastrectomy is technically more simple and shorter surgery time than the Roux-en-Y Gastric Bypass and maybe less painfull During surgery
Primary Postoperative morphine consumption The visual analog scale (VAS) will be used to measure pain on recovery room and hospitalization area. 48 hours
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