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S Ketamine Use in Total Abdominal Hysterectomy (SKET)

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ClinicalTrials.gov Identifier: NCT02543385
Recruitment Status : Withdrawn (Change of protocol title)
First Posted : September 7, 2015
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
KK Women's and Children's Hospital

Tracking Information
First Submitted Date  ICMJE September 3, 2015
First Posted Date  ICMJE September 7, 2015
Last Update Posted Date September 7, 2015
Study Start Date  ICMJE June 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2015)
S ketamine used in TAH [ Time Frame: 1 YEAR ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S Ketamine Use in Total Abdominal Hysterectomy
Official Title  ICMJE The Use of S Ketamine Versus Placebo During Target Controlled Intravenous Anaesthesia to Reduce Morphine Consumption and Side-Effects After Abdominal Hysterectomy: A Randomized Control Trial
Brief Summary This study investigates the effect of low dose S+ketamine compared to placebo on cumulative morphine consumption at 24 hours in women undergoing open abdominal hysterectomy with remifentanil-propofol target controlled infusion. It compares the adverse effect profile in patients receiving S+ketamine as compared to those who did not. Participants are randomly distributed in two groups of 45 patient's each.
Detailed Description

In recent times it has been suggested that NMDA receptor antagonist like ketamine when used in small doses helps reducing postoperative pain and opioid consumption without compromising wakefulness and or causing its psycho mimetic adverse effect .

The clinical utility of S+ ketamine as an adjuvant intra-operatively remains controversial. The NMDA receptor activation and subsequent biochemical process has been proven to play an important role in both hyperalgesia after tissue injury and the development of opioid tolerance. Various studies have reported the advantage of S+ ketamine over traditional balanced anaesthesia, but may lead to secondary hyperalgesia and increased opioid requirement in post operative period in both animals and healthy human volunteers. Other studies showed that 48 hours continuous administration of small-dose ketamine, together with patient-controlled analgesia (PCA) with morphine, or systemic, epidural co-administration of ketamine and opiates markedly reduced cumulative morphine. However, the dosage, route and timing of administration of S+-ketamine varied in different setting.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition  ICMJE Total Abdominal Hysterectomy
Intervention  ICMJE Drug: S Ketamine
S+ketamine will be given in group I only in the doses of 0.25mg/kg (iv bolus) before induction along with midazolam and 0. 25 mg/kg (iv bolus) 20 minutes prior to extubation
Study Arms  ICMJE
  • Active Comparator: SKET
    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 infusion according to Schnider model through target control infusion pump.
    Intervention: Drug: S Ketamine
  • Placebo Comparator: PLACEBO
    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 through target control infusion pump.
    Intervention: Drug: S Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 4, 2015)
0
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females above the age of 21 years old scheduled undergoing open abdominal hysterectomy with remifentanil-propofol TCI in KKH for benign condition (fibroids, adenomyosis),
  • Be willing and able to give written informed consent for participation in this study
  • ASA I/II patient's.

Exclusion Criteria:

  • Patient with 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 CNS, increased intraocular pressure and perforating ocular injuries, surgical procedures in the upper respiratory tract, etc
  • Patients with a h/o drug or alcohol abuse
  • Regular use of analgesics, or use of opioids within 12 hours of surgery
  • Patient on chronic use of benzodiazepine or neurololeptics
  • Patient on thyroid replacement hormone
  • H/o IHD,HTN,Thyroid disorder.
  • BMI> 30kg/m2.
  • H/o Psychiatric disorder.
  • Laproscopic surgery converted to open surgery.
  • Pregnant or breast feeding female's.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02543385
Other Study ID Numbers  ICMJE 2008/905/D
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party KK Women's and Children's Hospital
Study Sponsor  ICMJE KK Women's and Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account KK Women's and Children's Hospital
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP