Use of S+Ketamine During Target-Controlled Intravenous Anaesthesia After Abdominal Hysterectomy

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators want to investigate the effect of low dose S+ ketamine compared to placebo on cumulative morphine consumption at 24 hours in 90 women undergoing open abdominal hysterectomy with remifentanil-propofol target controlled infusion (TCI) in KK Women's and Children's Hospital. The secondary aims are to investigate the use of low dose S+ ketamine on the incidence of nausea, vomiting, pruritus (opioid side effect), sedation score and psycho mimetic assessment compared to placebo group. The investigators propose to conduct a double blinded, randomized controlled study in women undergoing open abdominal hysterectomy with remifentanil-propofol TCI. (1) Treatment Group: intravenous ketamine 0.5 mg/kg at the beginning and 0.5 mg/kg 20 minutes before extubation. (2) Control Group: intravenous normal saline (as placebo) at the beginning and 20 minutes before extubation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KK Women's and Children's Hospital
• Treatments: Esketamine; Ketamine; Propofol; Remifentanil

Criteria

Inclusion Criteria:

• Female ASA I/II patients above age of 21 years old scheduled gynecological open surgery for benign condition (fibroids, adenomyosis), who are willing and able to give written informed consent for participation in this study.

Exclusion Criteria:

• Contraindications to the use of S+ ketamine, as listed in the product label e.g. untreated or insufficiently treated thyroid hyperfunction, unstable angina pectoris or myocardial infarction within the last 6 months, diseases of the central nervous system, increased intraocular pressure and perforating ocular injuries, surgical procedures in the upper respiratory tract;

• History of drug or alcohol abuse;

• Regular use of analgesics, or use of opioids within 12 hours of surgery;

• Chronic use of benzodiazepine or neuroleptics;

• Thyroid replacement hormone;

• History of ischaemic heart disease, hypertension, psychiatric disorder;

• BMI> 30kg/m2;

• Laparoscopic surgery converted to open surgery;

• Pregnant or breast feeding females.