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Clinical Trials/NCT03862391
NCT03862391
Completed
Phase 4

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

Sakarya University1 site in 1 country60 target enrollmentJune 1, 2018

Overview

Phase
Phase 4
Intervention
Analgesics
Conditions
Agitated; State, Acute Reaction to Stress
Sponsor
Sakarya University
Enrollment
60
Locations
1
Primary Endpoint
Postanesthetic emergence agitation
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
November 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Sakarya University
Responsible Party
Principal Investigator
Principal Investigator

Gürkan Demir

Assistant Physician

Sakarya University

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.

Arms & Interventions

Postsurgical Pain

pain is defined as unpleasant sensation that can range from mild, localized discomfort to agony.

Intervention: Analgesics

Postanesthesia nausea and vomiting

nausea defined as feeling of sickness or discomfort in the stomach that may come with an urge to vomit.

Intervention: Antiemetics

Outcomes

Primary Outcomes

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'

Secondary Outcomes

  • postanesthetic nausea and vomiting(30 minutes after general anesthesia recovery)

Study Sites (1)

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