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Effect of Introperative Ketamine and Lidocaine Infusion on Postoperative Opioid Consumption in Posterior Spinal Fusion Surgery

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ClinicalTrials.gov Identifier: NCT04711668
Recruitment Status : Completed
First Posted : January 15, 2021
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Vedat Öztürk, Ataturk University

Tracking Information
First Submitted Date  ICMJE January 13, 2021
First Posted Date  ICMJE January 15, 2021
Last Update Posted Date January 15, 2021
Actual Study Start Date  ICMJE May 29, 2019
Actual Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2021)
postoperative opioid consumption [ Time Frame: postoperative 0-24 hours ]
postoperative PCA wit fentanyl
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2021)
postoperative pain score [ Time Frame: postoperative 0-24 hours ]
pain score is visual analogue scala
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Introperative Ketamine and Lidocaine Infusion on Postoperative Opioid Consumption in Posterior Spinal Fusion Surgery
Official Title  ICMJE The Effect of Introperative Ketamine and Lidocaine Infusion on Postoperative Opioid Consumption in Posterior Spinal Fusion Surgery - Double-Blind Randomized Controlled Study
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 i.v. done. In group K, 0.5 mg / kg i.v. ketamine bolus and 0.25 mg / kg / hr i.v. ketamine infusion was administered. In group L, 1.5 mg / kg i.v. lidocaine bolus and 1.5 mg / kg / hr i.v. lidocaine infusion was administered. In group P, i.v. 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 i.v. 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Spine Fusion
  • Postoperative Pain
Intervention  ICMJE
  • Drug: Ketamine
    intraoperative ketamine bolus and infusion
  • Drug: Lidocain
    intraoperative lidocain bolus and infusion
  • Drug: Saline
    intraoperative saline bolus and infusion
Study Arms  ICMJE
  • Experimental: Group Ketamin
    0.5 mg / kg i.v. ketamine bolus at induction and 0.25 mg / kg / hr i.v. ketamine infusion intraoperatively
    Intervention: Drug: Ketamine
  • Experimental: Group Lidokain
    1.5 mg / kg i.v. lidocaine bolus at induction and 1.5 mg / kg / hr i.v. lidocaine infusion intraoperatively
    Intervention: Drug: Lidocain
  • Placebo Comparator: Group Placebo
    i.v. saline (in the same volume and duration like group ketamine/lidokain)
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2021)
75
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2020
Actual Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • between the ages of 18-65, who have an ASA (American Society of Anesthesiologists) risk classification I-II-III

Exclusion Criteria:

  • Previous spinal surgery, Morbid obesity (BMI> 35 kg / m2), Lidocaine, ketamine or opioid allergy. Severe cardiac or pulmonary disease, Liver or kidney dysfunction Poorly controlled hypertension, Substance abuse, Chronic opioid use, Pregnancy, Psychiatric disorder, Cognitive impairment History of stroke, head injury, and intracranial mass or bleeding and patients who did not want to participate in the study were excluded from the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04711668
Other Study ID Numbers  ICMJE B.30.2.ATA.0.01.00/308
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Vedat Öztürk, Ataturk University
Study Sponsor  ICMJE Ataturk University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ataturk University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP