Total Abdominal HysterectomySKETNCT02543385
S Ketamine Use in Total Abdominal Hysterectomy
A study testing S Ketamine in people with Total Abdominal Hysterectomy, run by KK Women's and Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Total Abdominal Hysterectomy
- What is being tested?
- S Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- BMI> 30kg/m2.
- H/o Psychiatric disorder.
- Laproscopic surgery converted to open surgery.
- Pregnant or breast feeding female's.
About this study
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
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.
Read the 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.
- Conditions
- Total Abdominal Hysterectomy
- Being tested
- S Ketamine
- Keywords
- S Ketamine, Morphine, Consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S KetamineDrug
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 group | Role | What they receive |
|---|---|---|
| SKET | Active comparator | 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. Receives: Drug: S Ketamine |
| PLACEBO | Placebo comparator | 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. Receives: Drug: S Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
S ketamine used in TAH
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Change of protocol title
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Abdominal HysterectomyStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543385
- Sponsor's protocol ID
- 2008/905/D
- Acronym
- SKET
- Status last verified
- Aug 2026
- First submitted
- 3 Sep 2015
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02543385
- Acronym / sponsor ID
- SKET / 2008/905/D
- Conditions
- Total Abdominal Hysterectomy
- Keywords
- S Ketamine, Morphine, Consumption
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change of protocol title
- Enrolment
- 0 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SKET | Active comparator | Drug: S KetamineIntravenous 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. |
| PLACEBO | Placebo comparator | Drug: S KetamineIntravenous 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S KetamineS+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 | Drug | PLACEBO, SKET |
Primary outcome
S ketamine used in TAH
Time frame: 1 YEAR
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing S Ketamine in people with Total Abdominal Hysterectomy, run by KK Women's and Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S ketamine used in TAH (time frame: 1 YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.