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Opioid-free Anesthesia in Laparoscopic Cholecystectomies

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ClinicalTrials.gov Identifier: NCT05089526
Recruitment Status : Recruiting
First Posted : October 22, 2021
Last Update Posted : October 26, 2021
Sponsor:
Information provided by (Responsible Party):
Dr Kassiani Theodoraki, Aretaieion University Hospital

Tracking Information
First Submitted Date  ICMJE October 10, 2021
First Posted Date  ICMJE October 22, 2021
Last Update Posted Date October 26, 2021
Actual Study Start Date  ICMJE October 11, 2021
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2021)
  • 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"
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2021)
  • 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
  • sevoflurane consumption during general anesthesia [ Time Frame: change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 1-2 hours ]
    the sevoflurane vaporizer will be weighed before anesthetic induction and at the end of anesthesia and consequently sevoflurane consumption during anesthesia will be determined
  • 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 24 hours [ Time Frame: 24 hours postoperatively ]
    patients will be followed for cumulative tramadol consumption for 24 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
  • gastrointestinal recovery after surgery [ Time Frame: 24 hours postoperatively ]
    patients will be questioned regarding the time they first felt enteral sounds and the time they had their first flatus 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
  • fentanyl requirement during surgery [ Time Frame: intraoperatively ]
    dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
  • 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
  • incidence of chronic pain 1 month after surgery [ Time Frame: 1 month after surgery ]
    occurrence of chronic pain at the site of the operation 1 month after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement
  • incidence of chronic pain 3 months after surgery [ Time Frame: 3 months after surgery ]
    occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 10, 2021)
  • 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 Laparoscopic Cholecystectomies
Official Title  ICMJE Opioid-free Anesthesia With a Mixture of Dexmedetomidine-lidocaine-ketamine in Laparoscopic Cholecystectomies
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 laparoscopic cholecystectomies
Detailed Description

Inadequately treated postoperative pain after laparoscopic cholecystectomy may untowardly affect early recovery and also lead to the development of chronic pain. Laparoscopic surgery is associated with diminished postoperative pain but this does not mean that patients subjected to laparoscopic operations are not in need for analgesia intra- and postoperatively. Pneumoperitoneum can lead to postoperative discomfort and occasionally intense postoperative shoulder pain. Opioid-based analgesia is associated with side-effects, such as respiratory depression, postoperative nausea and vomiting and occasional induction of tolerance and hyperalgesia.

Therefore, in recent years research has focused on the quest for non-opioid-based regimens for perioperative analgesia in the context of multimodal analgesic techniques. These techniques have been shown to possess significant advantages, such as allowing earlier mobilization after surgery, early resumption of enteral feeding and reduced hospital length of stay. In this context, the intraoperative intravenous injection of lidocaine has been reported to improve postoperative pain control, reduce opioid consumption and improve the quality of postoperative functional recovery after general anesthesia. Intraoperative infusions of ketamine (an N-methyl-D-aspartate receptor inhibitor) have also been correlated with reduced pain scores and a decrease in analgesic requirements postoperatively. Lastly, dexmedetomidine is a highly selective alfa-2 adreno-ceptor agonist that provides sedation, analgesia, and sympatholysis. Its perioperative intravenous administration has been associated with a reduction in postoperative pain intensity, analgesic consumption and nausea. There is insufficient data in literature investigating the effect of combinations of these agents intraoperatively. It would be of interest to demonstrate whether the administration of combinations can be used towards the achievement of a completely opioid-free anesthetic regimen. Additionally, it can be hypothesized that the combination of non-opioid drugs with different targets can lead to enhanced postoperative recovery, an improved opioid-sparing effect and a decrease in the development of chronic pain as compared to the administration of opioids. Therefore, the aim of this study will be to investigate the effect of a combination of intravenous infusions of lidocaine-ketamine-dexmedetomidine versus fentanyl on recovery profile and postoperative pain after elective laparoscopic cholecystectomy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pain, Postoperative
  • Pain, Acute
  • Pain, Chronic
  • Cholecystectomy
  • Ketamine
  • Dexmedetomidine
  • Lidocaine
  • Central Nervous System Depressants
  • Analgesia
  • Analgesics
  • Analgesic Non-narcotic
Intervention  ICMJE
  • Drug: ketamine-lidocaine-dexmedetomidine

    In the KLD group, patients will be administered 0,25 mcg/kg Dexmedetomidine in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/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.

    Other Name: KLD group
  • Drug: fentanyl
    In the fentanyl group, patients will be administered 2 mcg/kg fentanyl in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of normal saline solution 0.9%. As maintenance, they will be receiving 1mL/10kg/h of normal saline solution 0.9%.
    Other Name: Control group
Study Arms  ICMJE
  • Active Comparator: ketamine-lidocaine-dexmedetomidine (KLD) group
    combination of ketamine-lidocaine-dexmedetomidine in one syringe
    Intervention: Drug: ketamine-lidocaine-dexmedetomidine
  • Active Comparator: fentanyl (control) group
    syringe of fentanyl
    Intervention: Drug: fentanyl
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: October 10, 2021)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • body mass index (BMI) >35 kg/m2
  • contraindications to local anesthetic administration or non-steroidal agents 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, PhD, DESA +306974634162 ktheodoraki@hotmail.com
Contact: Kyriakos Kyriazos kyriakos.kyriazos5@gmail.com
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05089526
Other Study ID Numbers  ICMJE lap-chol-opioid free
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
Responsible Party Dr Kassiani Theodoraki, Aretaieion University Hospital
Study Sponsor  ICMJE Aretaieion University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kassiani Theodoraki Aretaieion University Hospital
PRS Account Aretaieion University Hospital
Verification Date October 2021

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