Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03862391
Recruitment Status : Completed
First Posted : March 5, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Gürkan Demir, 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.

Condition or disease Intervention/treatment Phase
Agitated; State, Acute Reaction to Stress Drug: Analgesics Drug: Antiemetics Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Screening
Official Title: Evaluation of the Effects of Low Flow Anesthesia on Pain and Agitation in Patients After Recovery
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. postanesthetic nausea and vomiting [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   we have performed our study with laparotomic gynecological surgeries
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862391


Locations
Layout table for location information
Turkey
Sakarya University Training and Research Hospital
Sakarya, Turkey, 54100
Sponsors and Collaborators
Sakarya University
Investigators
Layout table for investigator information
Study Director: Ali Fuat Erdem, Professor Lecturer
Layout table for additonal information
Responsible Party: Gürkan Demir, Assistant Physician, Sakarya University
ClinicalTrials.gov Identifier: NCT03862391    
Other Study ID Numbers: Sakarya School of Medicine
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gürkan Demir, Sakarya University:
postanesthesia agitation
general anesthesia
low-flow anesthesia
Additional relevant MeSH terms:
Layout table for MeSH terms
Psychomotor Agitation
Stress Disorders, Traumatic, Acute
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Analgesics
Antiemetics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Autonomic Agents
Gastrointestinal Agents