COMPARISON OF DEXMEDETOMIDINE AND REMIFENTANIL FOR POSTOPERATIVE PAIN IN TRANSPHENOIDAL Pituitary SURGERY

Postoperative Pain Clinical Trial

Official title:

COMPARISON OF DEXMEDETOMIDINE AND REMIFENTANIL FOR POSTOPERATIVE PAIN IN TRANSPHENOIDAL Pituitary SURGERY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05772832
• Other study ID #: KocaeliUI
• Status: Completed
• Start date: November 17, 2021
• Est. completion date: February 22, 2023

Study information

• Verified date: March 2023
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In patients with pituitary adenoma scheduled for endoscopic transsphenoidal pituitary surgery, it was aimed to compare the efficacy of postoperative pain relief of a selective α-2 agonist "Dexmedetomidine" and the rapid and short-acting opioid "Remifentanil" using the "Numerical Rating Scale" (NRS) administered alongside propofol in perioperative maintenance anesthesia. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 22, 2023
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years old
• ASA-1 and ASA-2 patients

Exclusion Criteria:

• Patients in need of postoperative intensive care

Related Conditions & MeSH terms

• Pain, Postoperative
• Pituitary Diseases
• Postoperative Pain

Intervention

Drug:
• Dexmedetomidine
Efficacy of dexmedetomidine on postoperative pain in patients undergoing transsphenoidal pituitary surgery
• Remifentanyl
Efficacy of remifentanyl on postoperative pain in patients undergoing transsphenoidal pituitary surgery

Locations

Country	Name	City	State
Turkey	University of Kocaeli	Kocaeli	Izmit

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

Choi EK, Seo Y, Lim DG, Park S. Postoperative nausea and vomiting after thyroidectomy: a comparison between dexmedetomidine and remifentanil as part of balanced anesthesia. Korean J Anesthesiol. 2017 Jun;70(3):299-304. doi: 10.4097/kjae.2017.70.3.299. Epub 2017 Mar 15. — View Citation

Ge DJ, Qi B, Tang G, Li JY. Intraoperative Dexmedetomidine Promotes Postoperative Analgesia and Recovery in Patients after Abdominal Colectomy: A CONSORT-Prospective, Randomized, Controlled Clinical Trial. Medicine (Baltimore). 2015 Oct;94(43):e1727. doi: 10.1097/MD.0000000000001727. — View Citation

Hamed JME, Refaat HSM, Al-Wadaani H. Dexmedetomidine Compared to Remifentanil Infusion as Adjuvant to Sevoflurane Anesthesia during Laparoscopic Sleeve Gastrectomy. Anesth Essays Res. 2019 Oct-Dec;13(4):636-642. doi: 10.4103/aer.AER_126_19. Epub 2019 Dec 16. — View Citation

Hwang W, Lee J, Park J, Joo J. Dexmedetomidine versus remifentanil in postoperative pain control after spinal surgery: a randomized controlled study. BMC Anesthesiol. 2015 Feb 24;15:21. doi: 10.1186/s12871-015-0004-1. eCollection 2015. — View Citation

Javaherforooshzadeh F, Monajemzadeh SA, Soltanzadeh M, Janatmakan F, Salari A, Saeed H. A Comparative Study of the Amount of Bleeding and Hemodynamic Changes between Dexmedetomidine Infusion and Remifentanil Infusion for Controlled Hypotensive Anesthesia in Lumbar Discopathy Surgery: A Double-Blind, Randomized, Clinical Trial. Anesth Pain Med. 2018 Apr 28;8(2):e66959. doi: 10.5812/aapm.66959. eCollection 2018 Apr. — View Citation

Lee C, Kim YD, Kim JN. Antihyperalgesic effects of dexmedetomidine on high-dose remifentanil-induced hyperalgesia. Korean J Anesthesiol. 2013 Apr;64(4):301-7. doi: 10.4097/kjae.2013.64.4.301. Epub 2013 Apr 22. — View Citation

Rajan S, Hutcherson MT, Sessler DI, Kurz A, Yang D, Ghobrial M, Liu J, Avitsian R. The Effects of Dexmedetomidine and Remifentanil on Hemodynamic Stability and Analgesic Requirement After Craniotomy: A Randomized Controlled Trial. J Neurosurg Anesthesiol. 2016 Oct;28(4):282-90. doi: 10.1097/ANA.0000000000000221. — View Citation

Salman N, Uzun S, Coskun F, Salman MA, Salman AE, Aypar U. Dexmedetomidine as a substitute for remifentanil in ambulatory gynecologic laparoscopic surgery. Saudi Med J. 2009 Jan;30(1):77-81. — View Citation

Venn RM, Hell J, Grounds RM. Respiratory effects of dexmedetomidine in the surgical patient requiring intensive care. Crit Care. 2000;4(5):302-8. doi: 10.1186/cc712. Epub 2000 Jul 31. — View Citation

Virtanen R, Savola JM, Saano V, Nyman L. Characterization of the selectivity, specificity and potency of medetomidine as an alpha 2-adrenoceptor agonist. Eur J Pharmacol. 1988 May 20;150(1-2):9-14. doi: 10.1016/0014-2999(88)90744-3. — View Citation

Zheng Y, Cui S, Liu Y, Zhang J, Zhang W, Zhang J, Gu X, Ma Z. Dexmedetomidine prevents remifentanil-induced postoperative hyperalgesia and decreases spinal tyrosine phosphorylation of N-methyl-d-aspartate receptor 2B subunit. Brain Res Bull. 2012 Mar 10;87(4-5):427-31. doi: 10.1016/j.brainresbull.2012.01.009. Epub 2012 Jan 25. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain scale	Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )	at post anesthesia care unit (T1)
Primary	postoperative pain scale	Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )	2 hours after surgery (T2)
Primary	postoperative pain scale	Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )	8 hours after surgery (T3)
Primary	postoperative pain scale	Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )	24 hours after surgery (T4)
Secondary	need for analgesics	Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication	Additional analgesic drug requirements at post anesthesia care unit (T1)
Secondary	need for analgesics	Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication	Additional analgesic drug requirements at 2 hours after surgery (T2)
Secondary	need for analgesics	Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication	Additional analgesic drug requirements at 8 hours after surgery (T3)
Secondary	need for analgesics	Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication	Additional analgesic drug requirements at 24 hours after surgery (T4)
Secondary	Comparison of postoperative nausea-vomiting rate	Comparison of postoperative nausea-vomiting rate	at post anesthesia care unit (T1)
Secondary	Comparison of postoperative nausea-vomiting rate	Comparison of postoperative nausea-vomiting rate	2 hours after surgery (T2)
Secondary	Comparison of postoperative nausea-vomiting rate	Comparison of postoperative nausea-vomiting rate	8 hours after surgery (T3)
Secondary	Comparison of postoperative nausea-vomiting rate	Comparison of postoperative nausea-vomiting rate	24 hours after surgery (T4)