NCT03862391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

February 15, 2019

Last Update Submit

March 17, 2020

Conditions

Agitated; State, Acute Reaction to Stress

Keywords

postanesthesia agitationgeneral anesthesialow-flow anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • postanesthetic nausea and vomiting

    30 minutes after general anesthesia recovery

Study Arms (2)

Postsurgical Pain

ACTIVE COMPARATOR

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

Drug: Analgesics

Postanesthesia nausea and vomiting

ACTIVE COMPARATOR

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

Drug: Antiemetics

Interventions

AnalgesicsDRUG

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.

Postsurgical Pain
AntiemeticsDRUG

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

Postanesthesia nausea and vomiting

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswe have performed our study with laparotomic gynecological surgeries
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status 1 and 2, underwent gynicological laparotomic surgery under general anesthesia, followed up in PACU(postoperative care unit)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Training and Research Hospital

Sakarya, 54100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychomotor AgitationStress Disorders, Traumatic, Acute

Interventions

AnalgesicsAntiemetics

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesAutonomic AgentsGastrointestinal Agents

Study Officials

  • Ali Fuat Erdem, Professor

    Lecturer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Physician

Study Record Dates

First Submitted

February 15, 2019

First Posted

March 5, 2019

Study Start

June 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)