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

NCT03231683 | Completed Phase 2

• 1 other identifier: EC 200801014
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ketamine; Anesthesia; Morphine; Hysterectomy

Outcome Measures

Primary Outcomes (1)

• Post-operative Cumulative morphine consumption at 24 hours

  Post-operative Cumulative morphine consumption at 24 hours will be measured in the S-ketamine group compared to the placebo group

  1 day

Secondary Outcomes (3)

• Incidence of nausea

  1 day

• Incidence of vomiting

  1 day

• Incidence of pruritus

  1 day

Study Arms (2)

Esketamine

ACTIVE COMPARATOR

Esketamine and remifentanil to be given alongside with propofol through target control infusion pump.

Drug: Esketamine; Drug: Remifentanil; Drug: Propofol

Control

PLACEBO COMPARATOR

Saline and remifentanil to be given alongside with propofol through target control infusion pump.

Drug: Saline; Drug: Remifentanil; Drug: Propofol

Interventions

Esketamine DRUG

intravenous S+ketamine 0.25 mg/kg (i.v. bolus) at the beginning and 0.25 mg/kg (i.v. bolus) 20 minutes before extubation along with remifentanil according to Minto model and propofol according to Marsh model

Also known as: S+ ketamine

Esketamine

Saline DRUG

intravenous normal saline (as placebo, with similar volume) at the beginning and 20 minutes before extubation along with remifentanil according to Minto model and propofol according to Schnider model

Also known as: Sodium chloride

Control

Remifentanil DRUG

Either S+ketamine or saline at the beginning and 20 minutes before extubation along with remifentanil according to Minto model and propofol according to Schnider model

Also known as: Ultiva

Control; Esketamine

Propofol DRUG

Either S+ketamine or saline at the beginning and 20 minutes before extubation along with remifentanil according to Minto model and propofol according to Schnider model

Also known as: Diprivan

Control; Esketamine

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

Kk Women'S and Children'S Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Interventions

Esketamine; Ketamine; Sodium Chloride; Remifentanil; Propofol

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Officials

• Farida Ithnin, MBBCh

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: July 27, 2017
• Study Start: March 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 27, 2017

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)