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Ketamine for Postoperative Pain in Bariatric Surgery (KEPOBA)

13. november 2021 opdateret af: 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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

64

Fase

  • Fase 4

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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.
Medicin: Ketamine
0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navne:
  • Ketaminhydrochlorid
Medicin: Ketamine
0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navne:
  • Ketaminhydrochlorid
Medicin: Ketamine
0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
Andre navne:
  • Ketaminhydrochlorid
Medicin: Ketamine
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 navne:
  • Ketaminhydrochlorid
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.
Medicin: Ketamine
0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navne:
  • Ketaminhydrochlorid
Medicin: Ketamine
0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navne:
  • Ketaminhydrochlorid
Medicin: Ketamine
0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
Andre navne:
  • Ketaminhydrochlorid
Medicin: Ketamine
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 navne:
  • Ketaminhydrochlorid
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.
Medicin: Ketamine
0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navne:
  • Ketaminhydrochlorid
Medicin: Ketamine
0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navne:
  • Ketaminhydrochlorid
Medicin: Ketamine
0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
Andre navne:
  • Ketaminhydrochlorid
Medicin: Ketamine
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 navne:
  • Ketaminhydrochlorid
Placebo komparator: Control
The same amount of intravenous single pre-incisional injection of saline for bariatric patients in the operating room.
Medicin: Saline
Intravenous injection given pre-incisional in the operating room.
Andre navne:
  • Natriumchlorid
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.
Medicin: Ketamine
0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navne:
  • Ketaminhydrochlorid
Medicin: Ketamine
0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.
Andre navne:
  • Ketaminhydrochlorid
Medicin: Ketamine
0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.
Andre navne:
  • Ketaminhydrochlorid
Medicin: Ketamine
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 navne:
  • Ketaminhydrochlorid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Lithuanian University of Health Sciences

Efterforskere

  • Studiestol: Aurika Karbonskienė, MDPhDAssProf, Lithuanian University of Health Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. juli 2015

Primær færdiggørelse (Faktiske)

30. marts 2017

Studieafslutning (Forventet)

6. juni 2023

Datoer for studieregistrering

Først indsendt

14. december 2017

Først indsendt, der opfyldte QC-kriterier

1. januar 2018

Først opslået (Faktiske)

3. januar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. november 2021

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BEC-MF-713

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