Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators aimed to compare postanesthetic agitation in patients undergoing laparotomic gynecological surgery under general anesthesia using sevoflurane at a fresh gas flow rate of 2 L / min with fresh gas flow rate of 0.5 L / min.

Detailed Description
-----------------
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.

Official Title
-----------------
Evaluation of the Effects of Low Flow Anesthesia on Pain and Agitation in Patients After Recovery

Conditions
-----------------
Agitated; State, Acute Reaction to Stress

Intervention / Treatment
-----------------
* Drug: Analgesics
* Drug: Antiemetics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status 1 and 2, underwent gynicological laparotomic surgery under general anesthesia, followed up in PACU(postoperative care unit) Exclusion Criteria: ASA 3 or 4, mental retardation, psychiatric disease, history of malignant hyperthermia in patient or her family, neurological disease, morbid obesity, history of asthma and follow-up in the intensive care unit.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Postsurgical Pain<br>pain is defined as unpleasant sensation that can range from mild, localized discomfort to agony. | Drug: Analgesics<br>* 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.<br>|
| Active Comparator: Postanesthesia nausea and vomiting<br>nausea defined as feeling of sickness or discomfort in the stomach that may come with an urge to vomit. | Drug: Antiemetics<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postanesthetic emergence agitation | 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' | 30 minutes after general anesthesia recovery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postanesthetic nausea and vomiting | 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 | 30 minutes after general anesthesia recovery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postanesthesia agitation, general anesthesia, low-flow anesthesia