Opioid Sparing Analgesia Continuous Intraoperative Infusion of Dexmedetomidine Versus Lidocaine for Laparoscopic Cholecystectomy
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|ClinicalTrials.gov Identifier: NCT05788393|
Recruitment Status : Not yet recruiting
First Posted : March 28, 2023
Last Update Posted : March 28, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Analgesia||Drug: Dexmedetomidine Injection [Precedex] Drug: Lidocaine IV||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|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|
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.
- 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".
- 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.
- First call for rescue analgesic (Nalbuphine) [ Time Frame: 1 day ]
- The total postoperative Nalbuphine consumption [ Time Frame: 1 day ]
- Intraoperative automated non-invasive blood pressure monitoring. [ Time Frame: 1 hour ]
- Intraoperative electrocardiogram (ECG) heart rate monitoring. [ Time Frame: 1 hour ]
- The mean duration of PACU stay. [ Time Frame: 3 hours ]
- Side effects of study drugs. [ Time Frame: 1 hour ]
- Satisfaction of the patients questionnaire [ Time Frame: 1 day ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patient's status ASA status-I and II.
- Patients age above 18 years old.
- Patients scheduled for laparoscopic cholecystectomy.
- 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
- Breast feeding
- Woman under hormonal treatment
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
|Contact: Mina D. Hanna, Drfirstname.lastname@example.org|
|Principal Investigator:||Mohamed S. Saad, Dr||Assiut university hospitals|
|Responsible Party:||Mina Daniel Hanna, Primary investigator, Assiut University|
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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