- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03862391
Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?
Evaluation of the Effects of Low Flow Anesthesia on Pain and Agitation in Patients After Recovery
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Sakarya, Kalkun, 54100
- Sakarya University Training and Research Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Postsurgical Pain
pain is defined as unpleasant sensation that can range from mild, localized discomfort to agony.
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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.
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Aktiv komparator: Postanesthesia nausea and vomiting
nausea defined as feeling of sickness or discomfort in the stomach that may come with an urge to vomit.
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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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postanesthetic emergence agitation
Tidsramme: 30 minutes after general anesthesia recovery
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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postanesthetic nausea and vomiting
Tidsramme: 30 minutes after general anesthesia recovery
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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
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30 minutes after general anesthesia recovery
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Ali Fuat Erdem, Professor, Lecturer
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Sygdomme i nervesystemet
- Neurologiske manifestationer
- Neuroadfærdsmæssige manifestationer
- Dyskinesier
- Psykomotoriske lidelser
- Traumer og stressor-relaterede lidelser
- Stresslidelser, traumatiske
- Psykomotorisk agitation
- Stresslidelser, Traumatisk, Akut
- Lægemidlers fysiologiske virkninger
- Autonome agenter
- Agenter fra det perifere nervesystem
- Sensoriske systemagenter
- Gastrointestinale midler
- Analgetika
- Antiemetika
Andre undersøgelses-id-numre
- Sakarya School of Medicine
Plan for individuelle deltagerdata (IPD)
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