Ketamine for Postoperative Pain in Bariatric Surgery (KEPOBA)
13. november 2021 oppdatert av: Greta Kasputytė, Lithuanian University of Health Sciences
The Effects of Ketamine on Postoperative Pain After Intraoperative Remifentanil Infusions in Bariatric Surgery
The aim of this study was to evaluate an effect of pre - incisional single injection of low-dose ketamine on postoperative pain after remifentanil infusion in patients undergoing laparoscopic gastric bypass and gastric plication surgery.
Ketamine is an old general anaesthetic.
Low doses of it might be used as a adjunct in postoperative analgesia.The investigators expect that the low-dose ketamine reduces postoperative pain after bariatric surgeries.
Studieoversikt
Status
Påmelding etter invitasjon
Intervensjon / Behandling
Detaljert beskrivelse
Effective postoperative pain management enhances early postoperative rehabilitation and may improve outcomes of surgical treatment.
New analgetic medications and combinations of these are sought for optimal analgesia with lowest possible incidence of side effects.
One of the method of multimodal analgesia is a combination of opioids and adjuvant agents, such as ketamine.
To our knowledge, the role of ketamine in the treatment of postoperative pain after bariatric surgeries is poorly researched.
The investigators hypothesize that ketamine, acting through the N-methyl-D-aspartate receptor (NMDA) and opioid receptors, provides favourable conditions for adequate post-operative pain management.
Studietype
Intervensjonell
Registrering (Forventet)
64
Fase
- Fase 4
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- II or III The American Society of Anesthesiologists (ASA) physical status
- age > 18 years
- bariatric surgery with general remifentanil anesthesia
Exclusion Criteria:
- anamnesis of using opioids for the treatment of chronic pain
- opioid dependence
- younger than 18 years
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Treatment1
0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room.
|
0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navn:
0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navn:
0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
Andre navn:
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
Andre navn:
|
|
Aktiv komparator: Treatment2
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room.
|
0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navn:
0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navn:
0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
Andre navn:
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
Andre navn:
|
|
Aktiv komparator: Treatment3
0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
|
0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navn:
0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navn:
0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
Andre navn:
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
Andre navn:
|
|
Placebo komparator: Control
The same amount of intravenous single pre-incisional injection of saline for bariatric patients in the operating room.
|
Intravenous injection given pre-incisional in the operating room.
Andre navn:
|
|
Aktiv komparator: Treatment4
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
|
0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navn:
0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navn:
0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
Andre navn:
0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative pain intensity
Tidsramme: On the first postoperative day
|
Comparison of pain intensity will be recorded in both groups every 15 min in Post Anesthesia Care Unit (PACU) for 2.5 hours.
Postoperative pain was treated with boluses of i.v.
morphine (3 mg) at 3 min.
intervals on request, if pain intensity exceeded the score of 5 according to the Numeric Pain Rating Scale (NPRS) (0-10).
After the transfer of patient's to a regular unit, pain intensity was recorded every 6 hours.
|
On the first postoperative day
|
|
Postoperative morphine requirements
Tidsramme: On the first postoperative day
|
Postoperative morphine requirements will be recorded in both groups in the PACU for 2.5 hours.
|
On the first postoperative day
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of side effects
Tidsramme: On the first postoperative day
|
Incidence of side effects will be recorded in both groups on the first postoperative day.
|
On the first postoperative day
|
|
Patients' satisfaction with postoperative analgesia
Tidsramme: On the second postoperative day
|
Patients' satisfaction with postoperative analgesia will be recorded in both groups on the second postoperative day.The subject could express their level of satisfaction in five possible levels, from "very satisfied" to "very dissatisfied".
|
On the second postoperative day
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Aurika Karbonskienė, MDPhDAssProf, Lithuanian University of Health Sciences
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
22. juli 2015
Primær fullføring (Faktiske)
30. mars 2017
Studiet fullført (Forventet)
6. juni 2023
Datoer for studieregistrering
Først innsendt
14. desember 2017
Først innsendt som oppfylte QC-kriteriene
1. januar 2018
Først lagt ut (Faktiske)
3. januar 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. november 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. november 2021
Sist bekreftet
1. november 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Postoperative komplikasjoner
- Smerte
- Nevrologiske manifestasjoner
- Smerter, postoperativt
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Sentralnervesystemdepressiva
- Agenter fra det perifere nervesystemet
- Analgetika
- Sensoriske systemagenter
- Anestesimidler, dissosiativ
- Anestesimidler, intravenøst
- Anestesimidler, general
- Bedøvelsesmidler
- Eksitatoriske aminosyreantagonister
- Eksitatoriske aminosyremidler
- Ketamin
Andre studie-ID-numre
- BEC-MF-713
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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