drugset / Trial / NCT07425444
Attenuate the Stress Response in Laparoscopic Cholecystectomy
RandomizedParallel-groupDouble-blindTreatment
Summary
Aims of this study are to compare the effectiveness of dexmedetomidine versus fentanyl-midazolam in attenuating hemodynamic stress response during laparoscopic cholecystectomy (mainly HR). And to assess the recovery profile, the pain and opioid requirements, the sedation profile, and any adverse events during the first 24 hrs postoperatively
Timeline
- Start
- 2026-02
- Primary completion
- 2027-02
- Completion
- 2027-04
Publications
- Results Kum CK, Goh PM, Isaac JR, Tekant Y, Ngoi SS. Laparoscopic cholecystectomy for acute cholecystitis. Br J Surg. 1994 Nov;81(11):1651-4. doi: 10.1002/bjs.1800811130.
- Results Bass EB, Pitt HA, Lillemoe KD. Cost-effectiveness of laparoscopic cholecystectomy versus open cholecystectomy. Am J Surg. 1993 Apr;165(4):466-71. doi: 10.1016/s0002-9610(05)80942-0.
- Results GARDOCKI JF, YELNOSKY J. A STUDY OF SOME OF THE PHARMACOLOGIC ACTIONS OF FENTANYL CITRATE. Toxicol Appl Pharmacol. 1964 Jan;6:48-62. doi: 10.1016/0041-008x(64)90021-3. No abstract available.
- Results Kohno T, Kumamoto E, Baba H, Ataka T, Okamoto M, Shimoji K, Yoshimura M. Actions of midazolam on GABAergic transmission in substantia gelatinosa neurons of adult rat spinal cord slices. Anesthesiology. 2000 Feb;92(2):507-15. doi: 10.1097/00000542-200002000-00034.
- Results Kosugi T, Mizuta K, Fujita T, Nakashima M, Kumamoto E. High concentrations of dexmedetomidine inhibit compound action potentials in frog sciatic nerves without alpha(2) adrenoceptor activation. Br J Pharmacol. 2010 Aug;160(7):1662-76. doi: 10.1111/j.1476-5381.2010.00833.x.
- Results Smith JE, King MJ, Yanny HF, Pottinger KA, Pomirska MB. Effect of fentanyl on the circulatory responses to orotracheal fibreoptic intubation. Anaesthesia. 1992 Jan;47(1):20-3. doi: 10.1111/j.1365-2044.1992.tb01946.x.
- Results Bucx MJ, van Geel RT, Scheck PA, Stijnen T. Cardiovascular effects of forces applied during laryngoscopy. The importance of tracheal intubation. Anaesthesia. 1992 Dec;47(12):1029-33. doi: 10.1111/j.1365-2044.1992.tb04195.x.
- Results Weatherill D, Spence AA. Anaesthesia and disorders of the adrenal cortex. Br J Anaesth. 1984 Jul;56(7):741-9. doi: 10.1093/bja/56.7.741. No abstract available.
- Results Derbyshire DR, Chmielewski A, Fell D, Vater M, Achola K, Smith G. Plasma catecholamine responses to tracheal intubation. Br J Anaesth. 1983 Sep;55(9):855-60. doi: 10.1093/bja/55.9.855.
- Results Siedlecki J. Disturbances in the function of cardiovascular system in patients following endotracheal intubation and attempts of their prevention by pharmacological bloackade of sympathetic system. Anaesth Resusc Intensive Ther. 1975 Apr-Jun;3(2):107-23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.5 ug/kg | Intravenous |
| Comparator | Fentanyl | Other / unclassified | 2 ug/kg | Intravenous |
| Comparator | Midazolam | Small molecule | 0.05 mg/kg | Intravenous |
Indications
No indication recorded.