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Opioid Sparing Analgesia Continuous Intraoperative Infusion of Dexmedetomidine Versus Lidocaine for Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05788393
Recruitment Status : Not yet recruiting
First Posted : March 28, 2023
Last Update Posted : March 28, 2023
Sponsor:
Information provided by (Responsible Party):
Mina Daniel Hanna, Assiut University

Study Description
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Brief Summary:
Opioid sparing analgesia: Continuous intraoperative infusion of dexmedetomidine versus lidocaine for laparoscopic cholecystectomy, a randomized double-blind clinical trial.

Condition or disease Intervention/treatment Phase
Analgesia Drug: Dexmedetomidine Injection [Precedex] Drug: Lidocaine IV Phase 4

Detailed Description:
Postoperative pain represents one of the most common complaints following surgeries. Despite advances in modern medicine, pain following surgical procedures is still a challenge for anesthetists, though significant progress made over the past decades. The mechanism of pain following laparoscopic procedures is thought to be multifactorial. The main causes of pain after laparoscopic cholecystectomy (LC) are pain from the incision site, pneumoperitoneum and cholecystectomy. Clinicians using different methods for analgesia after LC. like non-steroidal anti-inflammatory drugs, intraperitoneal local anesthetics, local anesthetics applied to the wound site, removal of the insufflation gas, paravertebral block (PVB), and epidural block. To date, the mainstay of management has been the administration of exogenous opioids such as morphine or fentanyl. However, pain is not always fully relieved by such agents, and often patients develop tolerance to them. The ever-increasing doses of opioids are clearly not without their adverse effects. In addition to that, many patients and even some clinicians wrongly believe that addiction can be inevitable after administration of opioids. Dexmedetomidine is an alpha 2-adrenergic agonist which is a relatively new drug used for procedural sedation. It has sedative and anxiolytic effects and is known for its analgesic potential owing to a reduction of sympathetic tone. Dexmedetomidine has dose-dependent effects, ranging from minimal to deep sedation. Moreover, except at doses that cause very deep sedation or general anesthesia, the sedation is reversible. These are unique properties among the sedative medications in common use. Dexmedetomidine does not impair the respiratory drive per se and seldom causes apnea. However, it has been shown to impair the respiratory responses to hypoxia and hypercapnia and can cause hemodynamic effects such as hypertension, hypotension and bradycardia. Systemic lidocaine has centrally and peripherally analgesic, anti-hyperalgesic and anti-inflammatory effects with reduced side-effects especially if used with appropriate dose. Recently, intravenous lidocaine infusion is considered a part of analgesic therapy regimen that decreases postoperative opioid requirements and enhances convalescence after major surgeries. Dexmedetomidine and lidocaine are common adjuvant medicine anesthetics during operation for the sedative and analgesic properties. Besides, some studies have proved that both are effective in relieving postoperative pain in adults. However, there are very limited studies comparing the effects of the two adjuvant analgesics on postoperative pain in patients undergoing laparoscopic cholecystectomy (LC).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: this study is to compare the effects of continuous intraoperative infusion of dexmedetomidine versus lidocaine as opioid sparing analgesia on patients undergoing laparoscopic cholecystectomy.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Opioid Sparing Analgesia Continuous Intraoperative Infusion of Dexmedetomidine Versus Lidocaine for Laparoscopic Cholecystectomy a Randomized Double-blind Clinical Trial
Estimated Study Start Date : January 1, 2024
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : February 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dexmedetomidine group
This group will receive continuous intraoperative dexmedetomidine IV infusion [1ug/kg dexmedetomidine over 15 min as a loading dose and 0.5ug/kg/h for maintenance].
 Drug: Dexmedetomidine Injection [Precedex]
dexmedetomidine group will receive continuous intraoperative dexmedetomidine IV infusion [1ug/kg dexmedetomidine over 15 min as a loading dose and 0.5ug/kg/h for maintenance].The continuous intraoperative IV infusion of study drug will be stopped 10 min before the end the surgical procedure.
Experimental: Lidocaine group
This group will receive continuous intraoperative lidocaine IV infusion [1.5 mg/kg lidocaine over 15 min as a loading dose and 1.5 mg/kg/h for maintenance].
 Drug: Lidocaine IV
lidocaine group will receive continuous intraoperative lidocaine IV infusion [1.5 mg/kg lidocaine over 15 min as a loading dose and 1.5 mg/kg/h for maintenance]. The continuous intraoperative IV infusion of study drug will be stopped 10 min before the end the surgical procedure.


Outcome Measures
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Primary Outcome Measures :
  1. Numeric Pain Rating Scale [ Time Frame: 15 minutes ]
    Numeric Pain Rating Scale (NPRS) will be explained to the patient to be able to choose the score that best expressed the intensity of pain postoperatively ranging from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable".


Secondary Outcome Measures :
  1. Richmond Agitation-Sedation Scale [ Time Frame: 15 minutes ]
    Richmond Agitation-Sedation Scale (RASS) will be used to evaluate the level of sedation in post-anesthesia care unit (PACU), It is a 10-point scale, with four levels of anxiety or agitation, one level denoting a calm and alert state, and 5 levels of sedation, ranging from +4 to -5, desirable score is 0 to -2.

  2. First call for rescue analgesic (Nalbuphine) [ Time Frame: 1 day ]
  3. The total postoperative Nalbuphine consumption [ Time Frame: 1 day ]
  4. Intraoperative automated non-invasive blood pressure monitoring. [ Time Frame: 1 hour ]
  5. Intraoperative electrocardiogram (ECG) heart rate monitoring. [ Time Frame: 1 hour ]
  6. The mean duration of PACU stay. [ Time Frame: 3 hours ]

Other Outcome Measures:
  1. Side effects of study drugs. [ Time Frame: 1 hour ]
  2. Satisfaction of the patients questionnaire [ Time Frame: 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient's status ASA status-I and II.
  • Patients age above 18 years old.
  • Patients scheduled for laparoscopic cholecystectomy.

Exclusion Criteria:

  • Patient refusal.
  • Patients with known allergy to dexmedetomidine or lidocaine.
  • Patients with significant hepatic dysfunction.
  • Patients with severe renal disease.
  • Patients with chronic pain.
  • Regular use analgesics, antidepressants or opioids in last month.
  • Any known convulsive disorder.
  • Significant heart disease.
  • Morbid obesity (BMI>35).
  • Patients with autoimmune disease
  • Patients on corticosteroid therapy
  • Pregnancy
  • Breast feeding
  • Woman under hormonal treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05788393


Contacts
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Contact: Mina D. Hanna, Dr +201211589667 mina.daniel12@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Mohamed S. Saad, Dr Assiut university hospitals
More Information
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Publications:

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Responsible Party: Mina Daniel Hanna, Primary investigator, Assiut University
ClinicalTrials.gov Identifier: NCT05788393    
Other Study ID Numbers: Analgesia in cholecystectomy
First Posted: March 28, 2023    Key Record Dates
Last Update Posted: March 28, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Lidocaine
Dexmedetomidine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
 Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents