Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04711668
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2021-01-13
Brief Title:
Effect of Introperative Ketamine and Lidocaine Infusion on Postoperative Opioid Consumption in Posterior Spinal Fusion Surgery
Sponsor:
Ataturk University
Organization:
Ataturk University
Study Overview
Official Title:
The Effect of Introperative Ketamine and Lidocaine Infusion on Postoperative Opioid Consumption in Posterior Spinal Fusion Surgery - Double-Blind Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective The primary aim of this study was to investigate the effect of ketamine and lidocaine on postoperative opioid consumption in posterior spinal fusion surgery
Materials and Methods Ethics committee approval was received from our faculty Seventy-five cases between the ages of 18-65 who have an ASA American Society of Anesthesiologists risk classification I-II-III in the preanesthetic evaluation planned to be operated by the Neurosurgery clinic for lumbar posterior spinal fusion surgery under elective conditions have been included in the study after the informed volunteer consent form was read and approved
The patients were randomly divided into 3 groups using the closed envelope method The ketamine group Group K n 25 the lidocaine group Group L n 25 and the placebo group Group P n 25 Propofol rocuronium and fentanyl iv done In group K 05 mg kg iv ketamine bolus and 025 mg kg hr iv ketamine infusion was administered In group L 15 mg kg iv lidocaine bolus and 15 mg kg hr iv lidocaine infusion was administered In group P iv saline in the same volume and duration was applied Maintenance of anesthesia was provided by propofol and remifentanil infusion The propofol and remifentanil doses were adjusted according to the BIS monitoring and the increase or decrease in basal blood pressure and heart rate values of 20 or more The BIS value was kept between 40-60 At the end of surgery infusions were closed After extubation the patients were taken to the recovery room Patient controlled analgesia PCA prepared with fentanyl was applied to the patients for postoperative analgesia The PCA device was attached for 24 hours postoperatively
Postoperative 0-4 hours 4-8 hours 8-24 hours and total fentanyl consumption of the patients were evaluated Pain scores were measured at 1 2 4 8 12 and 24 hours in the postoperative recovery room Intraoperative propofol and remifentanil consumption was recorded Tramadol 1 mg kg iv as rescue analgesia in patients with VAS pain score of 4 and above done Possible side effects due to opioid ketamine and lidocaine were followed
Materials and Methods Ethics committee approval was received from our faculty Seventy-five cases between the ages of 18-65 who have an ASA American Society of Anesthesiologists risk classification I-II-III in the preanesthetic evaluation planned to be operated by the Neurosurgery clinic for lumbar posterior spinal fusion surgery under elective conditions have been included in the study after the informed volunteer consent form was read and approved
The patients were randomly divided into 3 groups using the closed envelope method The ketamine group Group K n 25 the lidocaine group Group L n 25 and the placebo group Group P n 25 Propofol rocuronium and fentanyl iv done In group K 05 mg kg iv ketamine bolus and 025 mg kg hr iv ketamine infusion was administered In group L 15 mg kg iv lidocaine bolus and 15 mg kg hr iv lidocaine infusion was administered In group P iv saline in the same volume and duration was applied Maintenance of anesthesia was provided by propofol and remifentanil infusion The propofol and remifentanil doses were adjusted according to the BIS monitoring and the increase or decrease in basal blood pressure and heart rate values of 20 or more The BIS value was kept between 40-60 At the end of surgery infusions were closed After extubation the patients were taken to the recovery room Patient controlled analgesia PCA prepared with fentanyl was applied to the patients for postoperative analgesia The PCA device was attached for 24 hours postoperatively
Postoperative 0-4 hours 4-8 hours 8-24 hours and total fentanyl consumption of the patients were evaluated Pain scores were measured at 1 2 4 8 12 and 24 hours in the postoperative recovery room Intraoperative propofol and remifentanil consumption was recorded Tramadol 1 mg kg iv as rescue analgesia in patients with VAS pain score of 4 and above done Possible side effects due to opioid ketamine and lidocaine were followed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None