Morphine Consumption in the Obese Patients

Ketamine

Brief 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.

Intervention / Treatment

  • Lidocaine 2% Injectable Solution and ketamine (BEHAVIORAL)
    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 (DRUG)
    At the end of surgery, they will continue receiving analgesia according the schedule.

Condition or Disease

  • Pharmacological Action
  • Post Operative Pain
  • Opioid Use
  • Obesity, Morbid
  • Anesthesia Morbidity

Phase

Study Design

Study type: OBSERVATIONAL
Status: Completed
Study results: No Results Available
Age: 18 Years to 65 Years
Enrollment: 60 (ACTUAL)
Time Perspective: Retrospective
Observational Model: Cohort

Masking

Clinical Trial Dates

Start date: Jan 15, 2022 ACTUAL
Primary Completion: Mar 30, 2023 ACTUAL
Completion Date: Mar 31, 2023 ACTUAL
Study First Posted: Oct 24, 2022 ACTUAL
Last Updated: Apr 07, 2023

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Participant Groups

  • At the end of surgery, on the recovery room, this group will receive lidocaine (1 mg/kg/h) and Ketamine (0,15 mg/kg/h) for 90 minutes

  • At the end of surgery, on the recovery room, this group will receive placebo (normal salin solution) for 90 minutes

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 65
Age Groups: Adult / Older Adult
Healthy Volunteers: Yes

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

Primary Outcomes

  • The visual analog scale (VAS) will be used to measure pain on recovery room and hospitalization area.

Other Outcomes

  • The laparoscopic Sleeve Gastrectomy is technically more simple and shorter surgery time than the Roux-en-Y Gastric Bypass and maybe less painfull

More Details

NCT Number: NCT05591105
Other IDs: TIVA OFA Obese patients
Study URL: https://clinicaltrials.gov/study/NCT05591105
Last updated: Sep 29, 2023