Morphine Consumption in the Obese Patients

Opioid Use Clinical Trial

Official title:

Post-operative Morphine Consumption in Obese Patients Undergoing Laparoscopic Bariatric Surgery Following Ketamina and Lidocaine Perfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05591105
• Other study ID #: TIVA OFA Obese patients
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

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

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