KetaminePhase 2NCT03231683
Use of S+Ketamine During Target-Controlled Intravenous Anaesthesia After Abdominal Hysterectomy
A Phase 2 study testing Esketamine, Saline and Remifentanil in people with Ketamine and Anesthesia, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Ketamine, Anesthesia, Morphine
- What is being tested?
- Esketamine, Saline and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSingapore
- Study dates
- Mar 2014to May 2016
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- BMI> 30kg/m2;
- Laparoscopic surgery converted to open surgery;
- Pregnant or breast feeding females.
Trial locations and contacts
1 site in 1 country.
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 Controlled Trial
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.
Read the detailed description
A number of 90 American Society of Anesthesiologists (ASA) I and II patients undergoing elective open abdominal hysterectomies will be randomly distributed in two groups of 45 patient's each and assigned to receive one of the of the following:
- Treatment Group: 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 Marsh model through target control infusion pump.
- Control Group: 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.
Randomization procedure is performed by the unblinded study team investigator. Patients will be randomized to either the treatment or control groups with a 1:1 allocation ratio. Sequence generation will be performed using a computerized random number generator, employing a permuted block randomization scheme. Allocation concealment will be maintained by having the random numbers pre-generated by an off-site statistician who will not be involved in subject recruitment. Implementation will be via serially numbered opaque sealed envelopes.
Throughout the study period, blinded study members will perform drug administration and data collection, while unblinded study members will be in charge for the investigational drug storage, dispensing and preparation. Any premature unblinding (e.g. accidental unblinding, unblinding due a serious adverse event) of the investigational product will be promptly documented and explained. In the case of adverse effect or severe adverse effect requiring information on the study treatment to manage a patient, the treatment code of the patient will be unblinded.
- Conditions
- Ketamine, Anesthesia, Morphine, Hysterectomy
- Being tested
- Esketamine, Saline, Remifentanil, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Also called S+ ketamine
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
SalineDrug
Also called Sodium chloride
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
RemifentanilDrug
Also called Ultiva
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
PropofolDrug
Also called Diprivan
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
| Study group | Role | What they receive |
|---|---|---|
| Esketamine | Active comparator | Esketamine and remifentanil to be given alongside with propofol through target control infusion pump. Receives: Drug: Esketamine; Drug: Remifentanil; Drug: Propofol |
| Control | Placebo comparator | Saline and remifentanil to be given alongside with propofol through target control infusion pump. Receives: Drug: Saline; Drug: Remifentanil; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (3)
Incidence of nausea
The use of low dose S-ketamine will reduce the incidence of nausea / vomiting, pruritus (opioid side effect) compared to placebo in women undergoing open abdominal hysterectomy with remifentanil-propofol target controlled infusion.
Measured: 1 day
Incidence of vomiting
The use of low dose S-ketamine will reduce the incidence of nausea / vomiting, pruritus (opioid side effect) compared to placebo in women undergoing open abdominal hysterectomy with remifentanil-propofol target controlled infusion.
Measured: 1 day
Incidence of pruritus
The use of low dose S-ketamine will reduce the incidence of nausea / vomiting, pruritus (opioid side effect) compared to placebo in women undergoing open abdominal hysterectomy with remifentanil-propofol target controlled infusion.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study startMar 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KetamineStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 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
- Investigators
- Farida Ithnin, MBBCh, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231683
- Sponsor's protocol ID
- EC 200801014
- Status last verified
- Aug 2026
- First submitted
- 3 Sep 2015
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 Controlled Trial
- ClinicalTrials.gov ID
- NCT03231683
- Acronym / sponsor ID
- EC 200801014
- Conditions
- Ketamine, Anesthesia, Morphine, Hysterectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- Mar 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Jul 2017 (actual)
- 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.
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.
Detailed description
A number of 90 American Society of Anesthesiologists (ASA) I and II patients undergoing elective open abdominal hysterectomies will be randomly distributed in two groups of 45 patient's each and assigned to receive one of the of the following:
- Treatment Group: 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 Marsh model through target control infusion pump.
- Control Group: 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.
Randomization procedure is performed by the unblinded study team investigator. Patients will be randomized to either the treatment or control groups with a 1:1 allocation ratio. Sequence generation will be performed using a computerized random number generator, employing a permuted block randomization scheme. Allocation concealment will be maintained by having the random numbers pre-generated by an off-site statistician who will not be involved in subject recruitment. Implementation will be via serially numbered opaque sealed envelopes.
Throughout the study period, blinded study members will perform drug administration and data collection, while unblinded study members will be in charge for the investigational drug storage, dispensing and preparation. Any premature unblinding (e.g. accidental unblinding, unblinding due a serious adverse event) of the investigational product will be promptly documented and explained. In the case of adverse effect or severe adverse effect requiring information on the study treatment to manage a patient, the treatment code of the patient will be unblinded.
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 |
|---|---|---|
| Esketamine | Active comparator | Drug: Esketamine, Drug: Remifentanil, Drug: PropofolEsketamine and remifentanil to be given alongside with propofol through target control infusion pump. |
| Control | Placebo comparator | Drug: Saline, Drug: Remifentanil, Drug: PropofolSaline and remifentanil to be given alongside with propofol through target control infusion pump. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| EsketamineAlso: 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 according to Marsh model | Drug | Esketamine |
| SalineAlso: Sodium chlorideintravenous 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 | Drug | Control |
| RemifentanilAlso: UltivaEither 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 | Drug | Control, Esketamine |
| PropofolAlso: DiprivanEither 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 | Drug | Control, Esketamine |
Primary outcome
Post-operative Cumulative morphine consumption at 24 hours
Time frame: 1 day
Post-operative Cumulative morphine consumption at 24 hours will be measured in the S-ketamine group compared to the placebo group
3 secondary outcomes
Incidence of nausea
Time frame: 1 day
Incidence of vomiting
Time frame: 1 day
Incidence of pruritus
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Farida Ithnin, MBBCh principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Esketamine, Saline and Remifentanil in people with Ketamine and Anesthesia, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 1 inclusion and 9 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: finished, 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.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-operative Cumulative morphine consumption at 24 hours (time frame: 1 day). 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.