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The Role of Ketamine and Dexmedetomidine in Opioid-Sparing Analgesia

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ClinicalTrials.gov Identifier: NCT05474183
Recruitment Status : Recruiting
First Posted : July 26, 2022
Last Update Posted : July 26, 2022
Sponsor:
Information provided by (Responsible Party):
Mohamed Ahmed Hamed, Fayoum University Hospital

Tracking Information
First Submitted Date  ICMJE June 29, 2022
First Posted Date  ICMJE July 26, 2022
Last Update Posted Date July 26, 2022
Estimated Study Start Date  ICMJE August 5, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2022)
The total postoperative fentanyl consumption (μg) [ Time Frame: the first 48 hours postoperative ]
the total doses of postoperative fentanyl consumption in (μg)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2022)
Duration of mechanical ventilation [ Time Frame: the first 48 hours postoperative ]
Duration of mechanical ventilation (day)
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 The Role of Ketamine and Dexmedetomidine in Opioid-Sparing Analgesia
Official Title  ICMJE The Role of Ketamine and Dexmedetomidine in Opioid-Sparing Analgesia and Sedation in Adult Patients After Cardiac Surgery. A Randomized Clinical Trial
Brief Summary Optimal multimodal opioid-sparing analgesic technique is considered as one of the most important Enhanced recovery pathways (ERPs) or enhanced recovery after surgery (ERAS) interventions that mitigate the undesirable effects of surgical stress response. Implementation of ERP has been shown to reduce postoperative complications and shorten the hospital LOS.
Detailed Description

In this study, the investigator hypothesizes that by using continuous infusion of ketamine or dexmedetomidine in addition to NSAIDs, the investigator can reduce or completely eliminate opioid use in adult patients after cardiac surgery.

The anesthesia technique was composed of the following 10 steps:

  1. Premedication with oral Pregabalin 75 mg the night before surgery;
  2. For induction and maintenance of anesthesia: - Midazolam 0.02- 0.05 mg/kg bolus, -Fentanyl (cumulative dose 5-15 μg/kg), followed by continuousInfusion of Fentanyl; 2-3 μg/kg /h as a maintenance dose, Rocuronium: (0.6-1.0 mg/kg - intubation dose, followed by continuous Infusion of Rocuronium; 0.075-0.15 mg/kg/h as a maintenance dose, and Sevoflurane in a dose of 0.8-1.0 (MAC).
  3. Ventilation: Lung protective ventilation (Vt 6 ml/kg predicted body weight, + PEEP 5, + FiO2 60%), and we conducted a recruitment maneuver in order to prevent atelectasis.
  4. Monitoring: Routine monitors (ECG, SpO2, arterial line inserted using local anesthesia for pressure monitor and repeated ABG, Central line inserted after induction of anesthesia for monitoring CVP, ETCO2, core temperature through urinary catheter, and Activated Clotting Time (ACT) for monitoring of coagulation). Cerebral oximetry, and Bispectral Index (BIS) as an indicator of depth anesthesia was kept between 40 and 60. (5) Cardiopulmonary Bypass (CPB): Goal directed perfusion maintaining MAP ≥ 60, using Phenylephrine and Norepinephrine infusion. Additional propofol infusion (25 - 50µg/kg/min) was administered during CPB to maintain BIS between 40 and 60. Smooth conduct of CPB, with Mild hypothermia (28°C 32°C). Rewarming at the end of the procedure, Goal postop temperature >36 °C.

(6) Perioperative Glycemic Control: Insulin infusion, and the perioperative Goal glucose ≤ 150 - 180.

(7)Perioperative hemoglobin concentration: Goal hemoglobin transfusion trigger: 7.5 regardless of patient Age and Comorbidity. (8) Protamine: Post CPB protamine (heparin reversal) given up to the full dose (5 mg/kg after test dose) to return to baseline ACT.

(9) Multimodal analgesia: In addition to continuous infusion of Fentanyl, at the end of the surgery, Paracetamol: 1 gm IV infusion over 15 min was administered with the sternum closure, and Surgical Incision Field Block using 30 ml of Bupivacaine 0.5% just before dressing. The patient will then be transferred intubated to Surgical ICU (SICU). (10) In SICU: Postoperative analgesia will be carried out for all groups. All patients will receive IV fentanyl via patient-controlled analgesia (PCA) with (10 µg.mL-1, with a bolus of 15 µg, and lockout 10 minutes, maximum cumulative dose of 90µ.hr-1 and no background dose). Before extubation, analgesia will be given as nurse-controlled analgesia (NCA) with the same regimen, depending on the sudden rise in HR or MABP ≥20% of the baseline. The total of 24 h. opioid consumption will be recorded.

At this step, and for opioid-sparing analgesia and sedation, using the sealed envelope technique, patients will be randomly divided into three groups: Group (K): (n=30) will receive ketamine infusion of 1-2 μg/kg/min (0.12 mg/kg/h) titrated to the desired level of sedation. Group (D): (n=30) will receive Dexmedetomidine infusion 0.1- 0.2 μg/kg/hour titrated to desired level of sedation. Group (C): (n=30) will receive fentanyl only. All hemodynamic monitors used intraoperatively are continued in SICU, and in addition, the following parameters are used to monitor the level of analgesia and sedation -During mechanical ventilation: Richmond Agitation-Sedation Scale

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ketamine-Induced Mood Disorder
Intervention  ICMJE Drug: Ketamine
drug
Other Name: dexmedetomidine
Study Arms  ICMJE
  • Active Comparator: Group (K)
    Group (K): (n=30) will receive ketamine infusion 1-2 μg/kg/min (0.12 mg/kg/h) titrated to desired level of sedation.
    Intervention: Drug: Ketamine
  • Active Comparator: Group (D)
    Group (D): (n=30) will receive Dexmedetomidine infusion 0.1- 0.2 μg/kg/hour titrated to desired level of sedation.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Group (C)
    Group (C): (n=30) will receive fentanyl only.
    Intervention: Drug: Ketamine
Publications *

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2022)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 - 65 years
  • Ejection fraction (EF) > 35%
  • Elective isolated CABG
  • Valve surgery, Atrial septal defect (ASD) closure
  • Cross clamp time ≤ 90 min
  • Cardiopulmonary bypass time ≤ 120 min.

Exclusion Criteria:

  • Poor left ventricular function with intra-aortic balloon pump support
  • Recent myocardial infarction (last seven days)
  • Combined procedure (i.e., CABG + other heart/vascular procedure)
  • Emergency surgery, and Redo surgery,Hepatic or renal failure, creatinine >1.5 -History of neurological disorders or convulsions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mohamed Ahmed Hamed 01010509736 ext 002 mah07@fayoum.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05474183
Other Study ID Numbers  ICMJE H123
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: no plane
Current Responsible Party Mohamed Ahmed Hamed, Fayoum University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fayoum University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fayoum University Hospital
Verification Date July 2022

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