Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?

Phase 4

Completed

• Conditions: Agitated; State, Acute Reaction to Stress
• Interventions: Drug: Analgesics; Drug: Antiemetics

• Registration Number: NCT03862391
• Lead Sponsor: Sakarya University

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.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-05
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postsurgical Pain	Analgesics	pain is defined as unpleasant sensation that can range from mild, localized discomfort to agony.
Postanesthesia nausea and vomiting	Antiemetics	nausea defined as feeling of sickness or discomfort in the stomach that may come with an urge to vomit.

Primary Outcome Measures

Name	Time	Method
Postanesthetic emergence agitation	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'

Secondary Outcome Measures

Name	Time	Method
postanesthetic nausea and vomiting	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; 1. point: the patient has moderate nausea for less than 15 minutes; 2. point: the patient has nausea for more than 15 minutes; 3. point: the patient has retching or vomiting

Trial Locations

Locations (1)

Sakarya University Training and Research Hospital; 🇹🇷 Sakarya, Turkey