Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04529135
Status:
COMPLETED
Last Update Posted:
2022-06-23
First Post:
2020-08-11
Brief Title:
The Effect of Dexmedetomidine During Opioid Free Anesthesia on Postoperative Recovery After Gastrectomy
Sponsor:
Gangnam Severance Hospital
Organization:
Gangnam Severance Hospital
Study Overview
Official Title:
The Effect of Dexmedetomidine During Opioid Free Anesthesia on Postoperative Recovery After Gastrectomy A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
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:
Want to know the effect of dexmedetomidine during opioid free anesthesia on postoperative recovery after gastrectomy Patients undergoing open gastrectomy are divided into dexmedetomidine group and controlremifentanil group administered during surgery and compared with the speed of postoperative intestinal function recovery Based on our institutions previous record the average recovery time was 6 14 days Given that it is clinically significant to reduce recovery time by 20 Alpha 005 and Power 80 require 31 samples per group and assuming a 10 dropout rate the total number of samples needed is 68Subjects are patients aged 19 to 75 who are subject to open gastretomy planned by a gastric cancer The exclusion criteria include American Society of Anesthesiology grade 3 or higher patients who have previously been treated for cancer patients with cancer other than the stomach patients with drug allergies weight less than 60kg BMI 30 kgm2 patients who are unable to communicate and are unable to read consent eg illiteracy foreigners etc The research method is a Randomized double-blind controlled study and the assignment of both drugs is unknown and is used to maintain anesthesia in the form of continuous injection during surgery Primary outcome is the recovery period satisfying the following 1intestinal gas passage 2 tolerance of soft bland diet SBD for 24 hr 3 safe ambulation without assistance 4 no requirement iv analgesics after discontinuation of PCA VAS 4 5 no abnormal physical signs or laboratory test The secondary outcomes are maximum VAS post-operative hospital stay complications and readmission rate at 3 months FU time post-operative period analgesic requirement incidence of opioid related side effect
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None