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

Name: Dexamethasone 3 mg

Name: Dexamethasone 6 mg

Name: Dexamethasone 12 mg

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP

SNPs

1 rs4680

The SNP rs4680 (c.472G > A) is a missense mutation leading to a four-fold reduction of the COMT enzyme.

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

HPO Nodes

HPO:

HP:0002018: Nausea

Genes 65

FSHR DNAJC6 KCNA1 EPAS1 RET VHL SDHB SLC25A11 PODXL SLC7A7 EXT2 SDHC ALDOB HTRA2 FSHR SAA1 RRM2B SDHAF2 CYP11B1 GLA LPL MAX MGME1 HELLPAR PINK1 PRKN CACNA1D POLG ETFDH ETFA TP53 TNF CD46 DLST EDNRA SNCA NAGS SLC1A3 TMEM127 SDHB KIF1B MGME1 ESR1 SDHD ALDOB UCHL1 VPS13C APC SDHD CYP11B2 VHL RET SDHA PARK7 MDH2 CFI TYMP CFH INHBA FH LRRK2 HMBS ETFB KCNJ5 SERPING1

Protein Mutations 3

S253N V158M Y129S

SNP 1

rs4680

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