S Ketamine Use in Total Abdominal Hysterectomy (SKET)

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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: September 3, 2015
• First Posted Date: September 7, 2015
• Last Update Posted Date: September 7, 2015
• Study Start Date: June 2014
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 4, 2015): S ketamine used in TAH [ Time Frame: 1 YEAR ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: S Ketamine Use in Total Abdominal Hysterectomy
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Condition: Total Abdominal Hysterectomy

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: September 4, 2015): 0
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 2015
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02543385
• Other Study ID Numbers: 2008/905/D
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: KK Women's and Children's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: KK Women's and Children's Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: KK Women's and Children's Hospital
• Verification Date: September 2015