- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07597564
Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation
Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation: Prospective Randomized Double-blind Study
This randomized, double-blind, controlled clinical study will evaluate the effects of different dose combinations of intravenous metoprolol and sufentanil on cardiovascular responses during oral endotracheal intubation under general anesthesia.
Endotracheal intubation may cause transient increases in heart rate and blood pressure due to sympathetic stimulation. This study aims to determine whether metoprolol, in combination with different doses of sufentanil, can improve hemodynamic stability during and after intubation.
A total of 900 adult patients aged 18 to 65 years with American Society of Anesthesiologists physical status I or II who are scheduled for elective non-cardiac surgery under general anesthesia with endotracheal intubation will be enrolled. Participants will be randomly assigned to one of 30 groups according to the combination of metoprolol dose and sufentanil dose. Metoprolol doses include 0, 0.1, 0.2, 0.3, 0.4, and 0.5 mg/kg, and sufentanil doses include 0.1, 0.2, 0.3, 0.4, and 0.5 mcg/kg.
All participants will receive standardized anesthetic induction and maintenance. Hemodynamic changes will be observed for 10 minutes after intubation. The main outcome is the success rate of hemodynamic stability within 0 to 10 minutes after intubation. Secondary outcomes include the incidence of hypotension, hypertension, bradycardia, and tachycardia.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: Yanhua Guo
- Telefonnummer: +86-18050333902
- E-mail: guoyanhua19@126.com
Studiesteder
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350000
- Fujian Provincial Hospital
-
Kontakt:
- Yanhua Guo
- Telefonnummer: +86-18050333902
- E-mail: guoyanhua19@126.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age 18 to 65 years.
- American Society of Anesthesiologists physical status I or II.
- Scheduled for elective non-cardiac surgery.
- Planned general anaesthesia with endotracheal intubation.
Exclusion Criteria:
- Cardiovascular or respiratory diseases, such as uncontrolled hypertension or bronchial asthma.
- Current use of β-blockers.
- History of chronic drug use or alcohol abuse.
- Hepatic or renal impairment.
- Known allergy to any study drug.
- Anticipated difficult airway.
- Any other condition that may affect the conduct of the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Metoprolol 0 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Aktiv komparator: Metoprolol 0 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Aktiv komparator: Metoprolol 0 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Aktiv komparator: Metoprolol 0 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Aktiv komparator: Metoprolol 0 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Normal saline (0.9% NaCl) will be administered intravenously before anesthetic induction as placebo in a volume matched to the metoprolol intervention.
The study drug will be delivered through a dedicated intravenous catheter, and participants assigned to the placebo arm will receive a volume corresponding to the randomized dosing schedule used in the metoprolol groups.
|
|
Eksperimentel: Metoprolol 0.1 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.1 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.1 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.1 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.1 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.2 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.2 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.2 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.2 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.2 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.3 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.3 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.3 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.3 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.3 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.4 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.4 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.4 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.4 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.4 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.5 mg/kg + Sufentanil 0.1 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.5 mg/kg + Sufentanil 0.2 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.5 mg/kg + Sufentanil 0.3 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.5 mg/kg + Sufentanil 0.4 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
|
Eksperimentel: Metoprolol 0.5 mg/kg + Sufentanil 0.5 mcg/kg
|
Sufentanil will be administered intravenously during anesthetic induction at the assigned dose of 0.1, 0.2, 0.3, 0.4, or 0.5 mcg/kg.
Each participant will receive sufentanil in combination with the assigned metoprolol dose according to the randomized treatment arm.
Metoprolol will be administered intravenously before anesthetic induction at the assigned dose of 0, 0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg.
The study drug will be given through a dedicated intravenous catheter, and each participant will receive the dose according to the randomized treatment arm.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of participants achieving hemodynamic stability after tracheal intubation
Tidsramme: within 0-10 min after intubation
|
within 0-10 min after intubation
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
incidence of bradycardia
Tidsramme: within 0-10 min after intubation
|
within 0-10 min after intubation
|
|
incidence of tachycardia
Tidsramme: within 0-10 min after intubation
|
within 0-10 min after intubation
|
|
incidence of hypotension
Tidsramme: within 0-10 min after intubation
|
within 0-10 min after intubation
|
|
incidence of hypertension
Tidsramme: within 0-10 min after intubation
|
within 0-10 min after intubation
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
adverse event
Tidsramme: up to 24 hours postoperatively
|
up to 24 hours postoperatively
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Yanhua Guo, Fujian Provincial Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
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
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Farmaceutiske præparater
- Aminer
- Piperidiner
- Krystalloidopløsninger
- Isotoniske løsninger
- Løsninger
- Alkoholer
- Phenoxypropanolaminer
- Propanolaminer
- Aminoalkoholer
- Propanoler
- Fentanyl
- Metoprolol
- Sufentanil
- Salinopløsning
Andre undersøgelses-id-numre
- K2024-03-015/02
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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