Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-27 @ 6:27 PM
Study NCT ID:
NCT04910659
Status:
UNKNOWN
Last Update Posted:
2021-06-08
First Post:
2021-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask
Sponsor:
Ankara City Hospital Bilkent
Organization:
Study Overview
Official Title:
Effectiveness of Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
the aim of our study is to investigate if stimulation of the P6, LI4 and LI11 acupuncture points via laser acupuncture prevents sore throat caused by the classic laryngeal mask.
Detailed Description:
Our study is planned as a prospective, randomized, controlled, single blind. The details of the study are explained to the patients and their written informed consents are obtained.
Using the randomization program, the patients are divided into group 1 (acupuncture group) and group 2 (control group). Preoxygenation (100% oxygen with balloon and mask for 3 minutes) and midozolam 0.02 mg / kg and fentanyl 2 mcgr / kg are administered to both groups. In Group1, laser acupuncture is applied to each of the previously described P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds. In Group 2, same procedure is performed for 30 seconds while laser acupuncture closed. Then, propofol 2mg / kg is administered and a laryngeal mask is placed after 90 seconds in both groups. Maintenance anesthesia is provided with sevofurane and remifentanil infusion.
Using the randomization program, the patients are divided into group 1 (acupuncture group) and group 2 (control group). Preoxygenation (100% oxygen with balloon and mask for 3 minutes) and midozolam 0.02 mg / kg and fentanyl 2 mcgr / kg are administered to both groups. In Group1, laser acupuncture is applied to each of the previously described P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds. In Group 2, same procedure is performed for 30 seconds while laser acupuncture closed. Then, propofol 2mg / kg is administered and a laryngeal mask is placed after 90 seconds in both groups. Maintenance anesthesia is provided with sevofurane and remifentanil infusion.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: