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Opioid-free Anesthesia in Thyroidectomies

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ClinicalTrials.gov Identifier: NCT05243940
Recruitment Status : Recruiting
First Posted : February 17, 2022
Last Update Posted : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
Dr Kassiani Theodoraki, Aretaieion University Hospital

Tracking Information
First Submitted Date  ICMJE February 8, 2022
First Posted Date  ICMJE February 17, 2022
Last Update Posted Date April 20, 2022
Actual Study Start Date  ICMJE March 7, 2022
Estimated Primary Completion Date February 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2022)
  • change from baseline in Quality of Recovery (QoR)-40 score after surgery [ Time Frame: 24 hours postoperatively ]
    The QoR-40 is used to measure functional recovery and has been validated in patients undergoing general surgical procedures. Five general quality-of-recovery dimensions are measured within the QoR-40: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is graded on a five-point Likert scale, and the global scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)
  • pain score on arrival to Post-Anesthesia Care Unit (PACU) [ Time Frame: immediately postoperatively ]
    pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
  • pain score at discharge from Post-Anesthesia Care Unit (PACU) [ Time Frame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively ]
    pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
  • pain score 3 hours postoperatively [ Time Frame: 3 hours postoperatively ]
    pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
  • pain score 6 hours postoperatively [ Time Frame: 6 hours postoperatively ]
    pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
  • pain score 24 hours postoperatively [ Time Frame: 24 hours postoperatively ]
    pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
  • Nociception Level [ Time Frame: intraoperatively ]
    Nociception Level as measured via the NOL (Nociception Level) index, whose values vary from 0 to 100 (100 represents the maximum level of nociception and 0 represents total absence of nociception). The aim of the current study will be to record percentage of operative time during which NOL levels will be <25
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2022)
  • remifentanil requirement during anesthesia [ Time Frame: intraoperatively ]
    rescue remifentanil required intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
  • Post Anesthesia Care Unit (PACU) duration of stay [ Time Frame: immediately postoperatively ]
    duration of patient stay at PACU
  • sedation on arrival to Post-Anesthesia Care Unit [ Time Frame: immediately postoperatively ]
    sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain
  • sedation at discharge from Post-Anesthesia Care (PACU) Unit [ Time Frame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively ]
    sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain
  • time to first request for analgesia [ Time Frame: during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively ]
    the time for the first patient request for analgesia will be noted
  • morphine consumption in Post-Anesthesia Care Unit (PACU [ Time Frame: immediately postoperatively ]
    mg of morphine requested during patient PACU stay
  • tramadol consumption in the first 48 hours [ Time Frame: 48 hours postoperatively ]
    patients will be followed for cumulative tramadol consumption for 48 hours postoperatively
  • sleep quality [ Time Frame: 24 hours postoperatively ]
    subjective evaluation of sleep quality by patients, based on a sleep questionnaire (evaluation of sleep duration, number of nocturnal awakenings and marking of sleep quality)
  • first mobilization after surgery [ Time Frame: 24 hours postoperatively ]
    patients will be questioned regarding the time at which they mobilized after surgery
  • satisfaction from postoperative analgesia [ Time Frame: 24 hours postoperatively ]
    satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction
  • first fluid intake [ Time Frame: 24 hours postoperatively ]
    patients will be questioned regarding the time they had their first fluid intake
  • first solid intake [ Time Frame: 24 hours postoperatively ]
    patients will be questioned regarding the time they had their first solid intake
  • hospitalization time [ Time Frame: 96 hours postoperatively ]
    duration of hospital stay after surgery in hours
  • side effects intraoperatively [ Time Frame: intraoperatively ]
    patients will be monitored for side-effects of the administered agents intraoperatively
  • side effects postoperatively [ Time Frame: 48 hours postoperatively ]
    patients will be monitored for side-effects of the administered agents postoperatively
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 8, 2022)
  • time to emergence [ Time Frame: up to 2-3 hours after start of surgery] ]
    time from sevoflurane discontinuation to first patient response (eye opening)
  • time to extubation [ Time Frame: up to 2-3 hours after start of surgery] ]
    time from sevoflurane discontinuation to tracheal extubation
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Opioid-free Anesthesia in Thyroidectomies
Official Title  ICMJE Recovery Parameters and Nociception Levels in Opioid-free Versus Opioid Based Anesthesia for Thyroidectomy
Brief Summary The aim of this study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus fentanyl analgesia in elective thyroidectomies. Recovery parameters and nociception levels throughout the operation will be evaluated
Detailed Description

In the usual anesthetic practice opioids are often administered in the perioperative period for intraoperative analgesia to control the nociceptive pathway of pain and post-surgical pain management. However, in recent years, opioid Free Anesthesia (OFA) has become increasingly popular, in which opioid administration is avoided intraoperatively and minimized or avoided in the postoperative period.

Opioid-free anesthesia (OFA) has been shown to decrease postoperative complications associated with opioids, include sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression.

Therefore, the investigators aim to perform this study to determine a goal-directed approach, which targets adequate antinociception (e.g., by measuring nociceptive/antinociceptive balance) that could reduce the negative effects of excessive drug infusion, prevent postoperative pain and improve patient outcomes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pain, Post Operative
  • Pain, Acute
  • Pain, Chronic
  • Pain, Neuropathic
  • Pain, Nociceptive
  • Ketamine
  • Dexmedetomidine
  • Lidocaine
  • Fentanyl
  • Analgesia
  • Analgesics
  • Analgesics Non-narcotic
Intervention  ICMJE
  • Drug: dexmedetomidine-ketamine-lidocaine (DKL)

    patients will be administered 0.25 mcg/kg Dexmedetomidine in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1 mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations. As maintenance, they will be receiving

    1mL/10kg/h of the aforementioned solution.

  • Drug: remifentanil infusion
    remifentanil infusion under the Minto model (target controlled infusion-TCI aiming at 4ng/ml blood concentration
Study Arms  ICMJE
  • Active Comparator: dexmedetomidine-ketamine-lidocaine (DKL) group
    combination of dexmedetomidine-ketamine-lidocaine in one syringe
    Intervention: Drug: dexmedetomidine-ketamine-lidocaine (DKL)
  • Active Comparator: remifentanil (control) group
    remifentanil infusion (TCI Minto protocol)
    Intervention: Drug: remifentanil infusion
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: February 8, 2022)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2024
Estimated Primary Completion Date February 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients
  • American Society of Anesthesiologists (ASA) classification I-II
  • elective thyroidectomy

Exclusion Criteria:

  • body mass index (BMI) >35 kg/m2
  • contraindications to local anesthetic administration
  • systematic use of analgesic agents preoperatively
  • chronic pain syndromes preoperatively
  • neurological or psychiatric disease on treatment
  • pregnancy
  • severe hepatic or renal disease
  • history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
  • bradycardia(<55 beats/minute)
  • drug or alcohol abuse
  • language or communication barriers lack of informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: KASSIANI THEODORAKI, MD, PhD, DESA +306974634162 ktheodoraki@hotmail.com
Contact: Rammi Devadze, MD +306949535388 gurdevadze@gmail.com
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05243940
Other Study ID Numbers  ICMJE annie-rammi
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: No
Current Responsible Party Dr Kassiani Theodoraki, Aretaieion University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aretaieion University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: KASSIANI THEODORAKI, MD, PhD, DESA Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece
PRS Account Aretaieion University Hospital
Verification Date April 2022

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