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Report for Clinical Trial NCT01975727

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting - a Randomised, Placebo-controlled, Dose-finding Study

Postoperative nausea and vomiting (PONV) are frequent after surgery and anaesthesia. Dexamethasone is widely used as antiemetic for the prevention of PONV. Little is known about the efficacy of antiemetic drugs for the treatment of established PONV symptoms. No single randomised trial has been published so far that tests the efficacy of dexamethasone for the treatment of established PONV symptoms. In this trial the investigators want to test the antiemetic efficacy of three different doses of intravenous dexamethasone for the treatment of established PONV symptoms. In adjunct protocols of this study the investigators aim to establish a novel method to quantify the anti-nausea efficacy of an antiemetic drug, to study pharmacogenetics of PONV, and to further our understanding on the smoking status as a predictive factor of PONV.

NCT01975727 Postoperative Nausea and Vomiting Vomiting
MeSH:Nausea Vomiting Postoperative Nausea and Vomiting
HPO:Nausea Vomiting

4 Interventions

Name: Placebo

Description: Injection of placebo (saline 0.9%)
Type: Drug
Group Labels: 1

Injection of Placebo

Name: Dexamethasone 3 mg

Description: 10 ml Seringue with Dexamethasone
Type: Drug
Group Labels: 1

Dexamethasone 3 mg

Name: Dexamethasone 6 mg

Description: 10 ml Seringue with Dexamethasone
Type: Drug
Group Labels: 1

Dexamethasone 6 mg

Name: Dexamethasone 12 mg

Description: 10 ml Seringue with Dexamethasone
Type: Drug
Group Labels: 1

Dexamethasone 12 mg


Primary Outcomes

Description: Complete absence of any nausea and/or vomiting (including retching) in a previously nauseated or vomiting patient within 24 hours after administration of the study treatment.

Measure: Treatment efficacy of Dexamethasone for established PONV

Time: 24 hour follow up

Secondary Outcomes

Description: Free from PONV during the first 6 hours

Measure: Short term efficacity

Time: 6 hours

Description: Number of patients staying PONV free after rescue antiemetic during the first 24 postoperative hours

Measure: PONV free after rescue antiemtic

Time: 24 hour follow up

Description: quality of sleep during the first postoperative night (numerical rating scale ranging from 0 = no sleep at all to 10 = excellent sleep)

Measure: Quality of sleep

Time: 24 hour follow up

Description: any minor or major adverse effects during 24h.

Measure: Minor or major adverse effects

Time: 24 hour follow up

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V158M

The COMT enzyme possesses a frequent non-synonymous polymorphism that encodes for the substitution of valine (Val) by methionine (Met) at codon 158 (Val158Met). --- Val158Met ---

The COMT Val158Met polymorphism (rs4680) will be genotyped using a commercially available TaqMan® SNP genotyping assay (C_25746809_50, Applied Biosystems, Warrington, UK). --- Val158Met ---



HPO Nodes


HPO:
HP:0002013: Vomiting
Genes 263
PYCR2 NDUFA6 ACAT1 PMM2 GALT COQ2 ST3GAL5 KCNJ11 NDUFAF4 ND5 HLCS TRNS2 ND2 MLYCD MC2R POLG IVD BCKDHB ABCC8 ACADVL HFE POLG ETFDH COX3 PIGY PPM1D MRAP SERPING1 FOXP3 TRNS1 UCP2 GK CPOX C11ORF95 ND4 IRAK1 PDCD10 SHANK3 RELA GCDH TRNF AIP CPS1 SCNN1G CDH23 DGAT1 SLC12A1 CFI ALDH18A1 NDUFV1 TRMU NDUFS4 ALG11 TRNK CPT2 NDUFS3 MCCC1 ACAD8 ACP2 TRNW ALG3 CYTB NFIX SLC6A8 ELP1 NDUFS1 KMT2E RANBP2 OXCT1 PPOX MTHFD1 SERPING1 ABCC8 TYMP NDUFS6 ACADL NDUFAF3 RARS1 SCNN1A BCKDHA SERPING1 NDUFV1 ACADM NEUROG3 KRIT1 FBP1 ND3 HMGCL ALG8 TMEM126B CTNS HELLPAR CYP11A1 ND1 DHCR7 ACTG2 PCCB HSD3B2 TP53 CD46 SCNN1B DBH DGUOK BRAF EGFR ND3 TIMMDC1 HPRT1 STAR ALDOB NDUFAF5 GALC POLG NDUFS2 ACSF3 ALAD ACSF3 GALE ST3GAL5 NAGS MMAA INHBA COX2 NDUFS8 FLNA ND1 ADNP TRNK C1R TRNL1 SLC25A15 SSR4 MET SAR1B KCNJ11 SLC12A3 CD55 SLC7A7 CYTB TRNV PDSS2 NDUFB10 SAA1 ACAT1 NEUROG3 ND1 NAXD GLA ATRX LPL STK11 RET ATP6V0A4 SAR1B TRNL1 ND6 NNT COA8 CYP24A1 ACY1 ETFA ND2 CACNA1A EDNRA KCNJ1 MVK MTRR SLC1A3 NDUFS4 ND5 NDUFB11 CLMP STAT4 MVK DLD SLC22A5 HMGCL TCN2 CYP11B1 ARG1 TNFRSF1A SUGCT TYMP SLC25A13 PCCA D2HGDH LIPA SLC7A7 OTC MPI SMPD1 HMBS F12 NBAS TXNRD2 AVPR2 ATP6 ACADVL ZEB2 OPLAH TRNQ ASL ALPL PNPLA8 MMUT C1QA NUBPL MCCC2 PMM2 AVP COX1 CDH23 ALDOB NDUFA11 CYP11B2 HIBCH RRM2B AIMP1 NDUFS1 NDUFAF2 SLC25A15 NDUFV2 MEN1 SLC22A5 NR3C2 MRPS7 NDUFB9 HADH TNF BOLA3 FOXRED1 SPP1 NDUFS7 TRNV CTNNB1 AQP2 HNF1A NAGS FARSB GHSR ESR1 APC HNF4A NDUFAF1 CCM2 MMAB ALG11 ND6 MPV17 NDUFB3 ACADM CFH DBT PHGDH SYT1 CYP11A1 BTD ASS1 NDUFA1 HMGCS2 ETFB TRNC TRNW
Protein Mutations 3
S253N V158M Y129S
SNP 1
rs4680