Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?

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

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.

Study Overview

• Status: Completed
• Conditions: Agitated; State, Acute Reaction to Stress
• Intervention / Treatment: Drug: Analgesics; Drug: Antiemetics

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Sakarya, Turkey, 54100
    • Sakarya University Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Postsurgical Pain; pain is defined as unpleasant sensation that can range from mild, localized discomfort to agony.	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.
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.	Drug: 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

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

Collaborators and Investigators

• Sponsor: Sakarya University
• Investigators: Study Director: Ali Fuat Erdem, Professor, lecturer

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: general anesthesia; postanesthesia agitation; low-flow anesthesia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Psychomotor Agitation; Stress Disorders, Traumatic, Acute; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Gastrointestinal Agents; Analgesics; Antiemetics
• Other Study ID Numbers: Sakarya School of Medicine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No