Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?
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|ClinicalTrials.gov Identifier: NCT03862391|
Recruitment Status : Completed
First Posted : March 5, 2019
Last Update Posted : March 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Agitated; State, Acute Reaction to Stress||Drug: Analgesics Drug: Antiemetics||Phase 4|
Emergence agitation is a temporary state of mental anxiety that occurs during general anesthesia recovery. It is characterized by emergence agitation, hallucination, excitation, delusion and confusion. Increased hemorrhage due to hypertension may cause serious complications such as injury to the surgical site, patients' self-removal of surgical drains and catheters, and self-extubation. Due to these, emergence agitation results need for additional treatment, psychological stress and increased medical workload for patients and their families.
Emergence agitation after general anesthesia in adult patients was reported up to 20%. However, the ratios are very wide.
In our operating room, the investigators observed that patients with low flow anesthesia were less agitated in the recovery phase than patients with normal flow anesthesia. In our researches, the investigators have not found any studies on the agitation values of patients who underwent low flow anesthesia in the literature.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||Evaluation of the Effects of Low Flow Anesthesia on Pain and Agitation in Patients After Recovery|
|Actual Study Start Date :||June 1, 2018|
|Actual Primary Completion Date :||November 1, 2019|
|Actual Study Completion Date :||November 1, 2019|
Active Comparator: Postsurgical Pain
pain is defined as unpleasant sensation that can range from mild, localized discomfort to agony.
while patients are in the PACU after general anesthesia, if patients' VAS scores are higher than 3, we will give them 50 mg of deksketoprofen as analgesic.
Active Comparator: Postanesthesia nausea and vomiting
nausea defined as feeling of sickness or discomfort in the stomach that may come with an urge to vomit.
while patients are in the PACU after general anesthesia, if patient' Nausea and vomiting scores are higher than 1, we will give them 4 mg of ondansetron
- Postanesthetic emergence agitation [ Time Frame: 30 minutes after general anesthesia recovery ]
Emergence agitation is a temporary state of mental anxiety that occurs during general anesthesia recovery. It is characterized by emergence agitation, hallucination, excitation, delusion and confusion.
Emergence agitation is defined as the Riker sedation-agitation scale (SAS) score of 5 or more at any time in the PACU.
Riker sedation-agitation scale:
7 point is 'Dangerous agitation' 6 point is 'very agitated' 5 point is 'agitated' 4 point is 'calm and cooperative' 3 point is 'sedated' 2 point is 'very sedated'
1 point is 'unarousable'
- postanesthetic nausea and vomiting [ Time Frame: 30 minutes after general anesthesia recovery ]
The Nausea-Vomiting score will also assess and 4 mg of Ondansetron iv will be administered to those who had a score of 2 or more.
The Nausea-Vomiting score:
0 point: no nausea or vomiting
- point: the patient has moderate nausea for less than 15 minutes
- point: the patient has nausea for more than 15 minutes
- point: the patient has retching or vomiting
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862391
|Sakarya University Training and Research Hospital|
|Sakarya, Turkey, 54100|
|Study Director:||Ali Fuat Erdem, Professor||Lecturer|