Clinical trial NCT05772832: COMPARISON OF DEXMEDETOMIDINE AND REMIFENTANIL FOR POSTOPERATIVE PAIN IN TRANSPHENOIDAL Pituitary SURGERY
Official title: COMPARISON OF DEXMEDETOMIDINE AND REMIFENTANIL FOR POSTOPERATIVE PAIN IN TRANSPHENOIDAL Pituitary SURGERY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: DEXMEDETOMİDİNE
REMİFENTANYL
pituitary SURGERY
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing transsphenoidal pituitary surgery

Brief 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. .


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients in need of postoperative intensive care

Primary outcomes:
measure: postoperative pain scale
timeFrame: at post anesthesia care unit (T1)
measure: postoperative pain scale
timeFrame: 2 hours after surgery (T2)
measure: postoperative pain scale
timeFrame: 8 hours after surgery (T3)
measure: postoperative pain scale
timeFrame: 24 hours after surgery (T4)
Secondary outcomes:
measure: need for analgesics
timeFrame: Additional analgesic drug requirements at post anesthesia care unit (T1)
measure: need for analgesics
timeFrame: Additional analgesic drug requirements at 2 hours after surgery (T2)
measure: need for analgesics
timeFrame: Additional analgesic drug requirements at 8 hours after surgery (T3)
measure: need for analgesics
timeFrame: Additional analgesic drug requirements at 24 hours after surgery (T4)
measure: Comparison of postoperative nausea-vomiting rate
timeFrame: at post anesthesia care unit (T1)
measure: Comparison of postoperative nausea-vomiting rate
timeFrame: 2 hours after surgery (T2)
measure: Comparison of postoperative nausea-vomiting rate
timeFrame: 8 hours after surgery (T3)
measure: Comparison of postoperative nausea-vomiting rate
timeFrame: 24 hours after surgery (T4)
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: University of Kocaeli
state: Izmit
Study officials:
References:
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citation: 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.
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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.