Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?

NCT ID: NCT03862391

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-11-01

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.

Conditions

Agitated; State, Acute Reaction to Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Postsurgical Pain

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

Group Type: ACTIVE_COMPARATOR

Analgesics

Intervention Type: DRUG

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.

Postanesthesia nausea and vomiting

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

Group Type: ACTIVE_COMPARATOR

Antiemetics

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

Gürkan Demir

Assistant Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Fuat Erdem, Professor

Role: STUDY_DIRECTOR

Lecturer

Locations

Sakarya University Training and Research Hospital

Sakarya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Sakarya School of Medicine

Identifier Type: -

Identifier Source: org_study_id