Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?

Agitated; State, Acute Reaction to Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862391
• Other study ID #: Sakarya School of Medicine
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: March 2020
• Source: Sakarya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Agitated; State, Acute Reaction to Stress
• Psychomotor Agitation
• Stress Disorders, Traumatic, Acute

Intervention

Drug:
• Analgesics
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.
• Antiemetics
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

Locations

Country	Name	City	State
Turkey	Sakarya University Training and Research Hospital	Sakarya

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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