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

NCT05788393 | Completed Phase 4 DMC

• 1 other identifier: Analgesia in cholecystectomy
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale

  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".

  15 minutes

Secondary Outcomes (6)

• Richmond Agitation-Sedation Scale

  15 minutes

• First call for rescue analgesic (Nalbuphine)

  1 day

• The total postoperative Nalbuphine consumption

  1 day

• Intraoperative automated non-invasive blood pressure monitoring.

  1 hour

• Intraoperative electrocardiogram (ECG) heart rate monitoring.

  1 hour

Other Outcomes (2)

• Side effects of study drugs.

  1 hour

• Satisfaction of the patients questionnaire

  1 day

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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]

Lidocaine group

EXPERIMENTAL

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

Interventions

Lidocaine IV DRUG

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.

Lidocaine group

Dexmedetomidine Injection [Precedex] DRUG

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.

Dexmedetomidine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospitals

Asyut, Asyut Governorate, Egypt

Location

Related Publications (8)

• Mitra S, Carlyle D, Kodumudi G, Kodumudi V, Vadivelu N. New Advances in Acute Postoperative Pain Management. Curr Pain Headache Rep. 2018 Apr 4;22(5):35. doi: 10.1007/s11916-018-0690-8.

  PMID: 29619627 BACKGROUND

• Meera A. Pain and Opioid Dependence: Is it a Matter of Concern. Indian J Palliat Care. 2011 Jan;17(Suppl):S36-8. doi: 10.4103/0973-1075.76240.

  PMID: 21811368 BACKGROUND

• Barends CR, Absalom A, van Minnen B, Vissink A, Visser A. Dexmedetomidine versus Midazolam in Procedural Sedation. A Systematic Review of Efficacy and Safety. PLoS One. 2017 Jan 20;12(1):e0169525. doi: 10.1371/journal.pone.0169525. eCollection 2017.

  PMID: 28107373 BACKGROUND

• Batko I, Koscielniak-Merak B, Tomasik PJ, Kobylarz K, Wordliczek J. Lidocaine as an element of multimodal analgesic therapy in major spine surgical procedures in children: a prospective, randomized, double-blind study. Pharmacol Rep. 2020 Jun;72(3):744-755. doi: 10.1007/s43440-020-00100-7. Epub 2020 Apr 15.

  PMID: 32297162 BACKGROUND

• Bellon M, Le Bot A, Michelet D, Hilly J, Maesani M, Brasher C, Dahmani S. Efficacy of Intraoperative Dexmedetomidine Compared with Placebo for Postoperative Pain Management: A Meta-Analysis of Published Studies. Pain Ther. 2016 Jun;5(1):63-80. doi: 10.1007/s40122-016-0045-2. Epub 2016 Feb 10.

  PMID: 26861737 BACKGROUND

• Weibel S, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Afshari A, Kranke P. Efficacy and safety of intravenous lidocaine for postoperative analgesia and recovery after surgery: a systematic review with trial sequential analysis. Br J Anaesth. 2016 Jun;116(6):770-83. doi: 10.1093/bja/aew101.

  PMID: 27199310 BACKGROUND

• Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.

  PMID: 3785962 BACKGROUND

• Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.

  PMID: 12421743 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohamed S. Saad, Dr

  Assiut university hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Model Details: this study is to compare the effects of continuous intraoperative infusion of dexmedetomidine versus lidocaine as opioid sparing analgesia on patients undergoing laparoscopic cholecystectomy.

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: March 28, 2023
• Study Start: April 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: January 21, 2026

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)