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Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)? (THC)

I

Insel Gruppe AG, University Hospital Bern

Status

Terminated

Conditions

Vomiting
Nausea

Treatments

Drug: THC 9-d-tetra hydro cannabinol

Study type

Interventional

Funder types

Other

Identifiers

NCT00695487
THC-001
KEK240_07

Details and patient eligibility

About

The investigators evaluate if intravenously applied THC (Cannabis) reduces postoperative Nausea and vomiting. THC will be given during anesthesia before emergence. We measure how long and how effective it reduces PONV

Enrollment

320 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ASA I-III
  • elective open and laparoscopic surgery >1hour

Exclusion criteria

  • ambulatory surgery
  • pregnancy, breast feeding
  • >ASA III
  • BMI >35
  • antipsychotic, antiemetic, cytostatic therapy
  • major cardiovascular, renal, hepatic, central nervous system disease
  • current chronic cannabis consumption and hard drug abuse
  • schizophrenia
  • preoperative nausea and vomiting, vestibular disease
  • not speaking german or french
  • refusal to participate

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

320 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Receives 0.125mg/kg THC before emergence
Treatment:
Drug: THC 9-d-tetra hydro cannabinol
2
Placebo Comparator group
Description:
Receives NaCl before emergence
Treatment:
Drug: THC 9-d-tetra hydro cannabinol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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