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Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?

Primary Purpose

Agitated; State, Acute Reaction to Stress

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Analgesics
Antiemetics
Sponsored by
Sakarya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Agitated; State, Acute Reaction to Stress focused on measuring postanesthesia agitation, general anesthesia, low-flow anesthesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sakarya University Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Postsurgical Pain

Postanesthesia nausea and vomiting

Arm Description

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

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

Outcomes

Primary Outcome Measures

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'

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2019
Last Updated
March 17, 2020
Sponsor
Sakarya University
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1. Study Identification

Unique Protocol Identification Number
NCT03862391
Brief Title
Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?
Official Title
Evaluation of the Effects of Low Flow Anesthesia on Pain and Agitation in Patients After Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sakarya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitated; State, Acute Reaction to Stress
Keywords
postanesthesia agitation, general anesthesia, low-flow anesthesia

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Postsurgical Pain
Arm Type
Active Comparator
Arm Description
pain is defined as unpleasant sensation that can range from mild, localized discomfort to agony.
Arm Title
Postanesthesia nausea and vomiting
Arm Type
Active Comparator
Arm Description
nausea defined as feeling of sickness or discomfort in the stomach that may come with an urge to vomit.
Intervention Type
Drug
Intervention Name(s)
Analgesics
Intervention Description
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
Intervention Name(s)
Antiemetics
Intervention Description
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 Measure Information:
Title
Postanesthetic emergence agitation
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. 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'
Time Frame
30 minutes after general anesthesia recovery
Secondary Outcome Measure Information:
Title
postanesthetic nausea and vomiting
Description
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
Time Frame
30 minutes after general anesthesia recovery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
we have performed our study with laparotomic gynecological surgeries
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Fuat Erdem, Professor
Organizational Affiliation
Lecturer
Official's Role
Study Director
Facility Information:
Facility Name
Sakarya University Training and Research Hospital
City
Sakarya
ZIP/Postal Code
54100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?

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