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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

Injection of Placebo

Name: Dexamethasone 3 mg

Description: 10 ml Seringue with Dexamethasone

Type: Drug

Dexamethasone 3 mg

Name: Dexamethasone 6 mg

Description: 10 ml Seringue with Dexamethasone

Type: Drug

Dexamethasone 6 mg

Name: Dexamethasone 12 mg

Description: 10 ml Seringue with Dexamethasone

Type: Drug

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 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:
Nausea
Genes 59
FSHR NAGS SLC7A7 KCNJ5 ALDOB GLA SAA1 SNCA CYP11B1 SDHAF2 SERPING1 CYP11B2 FSHR VPS13C TYMP LPL UCHL1 KCNA1 MGME1 CFI ETFA PARK7 SLC25A11 ESR1 CD46 TNF KIF1B MAX VHL TP53 ETFDH LRRK2 APC PRKN RET SLC1A3 INHBA EDNRA HMBS SDHC FH DNAJC6 PINK1 TMEM127 PODXL HTRA2 ETFB HELLPAR SDHA SDHD MGME1 CFH DLST ALDOB MDH2 SDHB CACNA1D RRM2B POLG
Vomiting
Genes 258
CYP11A1 ACY1 RANBP2 AIMP1 NDUFA1 ND5 MPV17 NDUFB3 POLG TRNW COA8 ND6 HNF1A ND1 SLC25A15 HSD3B2 TRNS1 COQ2 CPS1 TRNV MCCC2 TYMP DBT MCCC1 ACADM SLC25A13 ETFA TYMP COX2 DHCR7 FBP1 NUBPL NDUFB10 SERPING1 TRNQ ACAD8 ACTG2 HMGCL BCKDHA CD55 STAT4 CYP24A1 CCM2 ND6 NBAS PMM2 CTNNB1 SCNN1B RELA CDH23 ALG11 NDUFAF5 HELLPAR PMM2 CPT2 NAXD TRNV CFH SUGCT NDUFV2 COX3 ND2 PPM1D RET HPRT1 GCDH TRMU HFE ABCC8 PCCB MMAB NDUFA11 OPLAH NDUFAF4 ALG8 MLYCD SLC7A7 ALDOB GLA BRAF CDH23 TRNW BTD SERPING1 PNPLA8 FARSB CPOX NDUFS2 NEUROG3 SLC22A5 BOLA3 SHANK3 HLCS ACAT1 CYP11B2 BCKDHB SCNN1G CFI NAGS CYTB GHSR ABCC8 TNFRSF1A KMT2E OTC CD46 SSR4 TNF SCNN1A ASS1 TP53 ST3GAL5 PPOX AIP FLNA INHBA SLC22A5 ACAT1 MC2R RARS1 GALC OXCT1 EGFR AQP2 PDSS2 NDUFV1 ELP1 NDUFS1 ACSF3 ACP2 MRPS7 ACADL ARG1 COX1 F12 ACADM AVP TRNF NDUFB11 SAR1B ALG11 ALPL TCN2 POLG DGAT1 NAGS MET SLC7A7 ACADVL HMGCL TXNRD2 TRNS2 ND3 SERPING1 NDUFS7 NNT UCP2 ST3GAL5 NDUFAF3 FOXP3 NDUFV1 TRNK ND4 SLC25A15 ND2 ALDH18A1 MMAA C1R NDUFS1 DBH KRIT1 SLC1A3 ND1 NDUFS4 LIPA HMBS CLMP ETFB ALAD ACADVL NDUFA6 SMPD1 SPP1 GALE AVPR2 GK GALT ALDOB TRNL1 SLC12A3 NDUFS3 ADNP MPI TRNL1 ND1 NDUFS8 KCNJ1 SAR1B ZEB2 SAA1 NDUFS6 ASL STAR MRAP TRNC POLG MVK MTHFD1 ATP6V0A4 HNF4A D2HGDH NDUFB9 LPL MEN1 CYP11B1 SLC12A1 CYP11A1 HADH STK11 CACNA1A C1QA TIMMDC1 TRNK SLC6A8 ESR1 ETFDH HIBCH APC FOXRED1 ALG3 NR3C2 EDNRA ND3 PDCD10 PIGY IRAK1 ACSF3 DGUOK C11ORF95 MMUT CTNS TMEM126B KCNJ11 ND5 PHGDH NDUFAF1 PCCA MVK HMGCS2 ATP6 NDUFAF2 IVD NEUROG3 ATRX NDUFS4 RRM2B KCNJ11 DLD