SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01975727

Developed by Shray Alag, 2019.
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 39
CFH APC VHL SERPING1 CACNA1D HMBS SAA1 CD46 KCNA1 RET GLA FH MDH2 SLC7A7 TYMP CFI ALDOB SDHAF2 TMEM127 INHBA SLC1A3 CYP11B1 CYP11B2 KCNJ5 NAGS RRM2B POLG MAX SDHA SDHB SDHC KIF1B SDHD MGME1 HELLPAR ETFA FSHR ETFB ETFDH
Vomiting
Genes 181
PIGY CFH CACNA1A MPV17 FLNA RANBP2 HNF1A PDSS2 GALC GALE RARS GALT ACADL ACADM ATRX TCN2 ACADVL ACAT1 AVP AIMP1 INHBA AVPR2 PPM1D CYP11A1 CYP11B1 CYP11B2 RRM2B POLG ACP2 CYP24A1 ETFA ETFB ETFDH MC2R APC CD55 HLCS ELP1 ACTG2 FARSB CDH23 HMBS ALG11 GCDH BCKDHA BCKDHB RELA HMGCL CD46 DBH HMGCS2 MCCC2 AIP MCCC1 CPOX TXNRD2 SSR4 CPS1 DBT ACY1 SLC7A7 CPT2 TYMP CFI COQ2 HNF4A AQP2 BOLA3 SLC1A3 ZEB2 COA8 SHANK3 NDUFS1 F12 STAR PHGDH NDUFV1 NAGS NDUFS4 KRIT1 MLYCD PPOX HELLPAR MEN1 ARG1 IVD MMAA GHSR SLC6A8 TRMU MRPS7 MET NBAS STK11 SAA1 OTC CCM2 LIPA GK FBP1 OXCT1 ATP6 GLA SLC12A1 TRNC SLC12A3 COX1 BRAF COX2 COX3 EGFR ST3GAL5 SUGCT CYTB MTHFD1 BTD KCNJ1 ABCC8 ASL HPRT1 DGUOK DHCR7 SLC25A15 MRAP KCNJ11 ND1 UCP2 SAR1B ND2 SLC22A5 ATP6V0A4 ND3 ND4 NAXD ND5 ASS1 ND6 SCNN1A SCNN1B SCNN1G SERPING1 ALDH18A1 ACSF3 DLD ALG8 TRNF C11ORF95 PNPLA8 SMPD1 ALAD NR3C2 CLMP ALG3 HSD3B2 TRNK TRNL1 CTNS HADH CTNNB1 TRNQ TNFRSF1A TRNS1 TRNS2 TRNV TRNW PDCD10 ALDOB MMAB PCCA PCCB NNT D2HGDH NEUROG3 MMUT DGAT1 MVK ALPL OPLAH PMM2 FOXP3 MPI