Non Elective Cesarean Section and Ketamine AnalgesiaPhase 4NCT03450499
Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section
A Phase 4 study testing Ketamine in people with Non Elective Cesarean Section and Ketamine Analgesia, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
This randomized double blind study will be conducted in pregnant woman planned for non elective cesarean section under spinal anesthesia. Ketamine group will receive intravenous 0.25 mg/kg and placebo group will receive same amount of normal saline after spinal anesthesia prior to skin incision. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Non Elective Cesarean Section and Ketamine Analgesia
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteNepal
- Study dates
- 1 Apr 2018to 7 Mar 2019
- Phase
- Phase 4
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • All women at term(>or =37 weeks of gestation)
- Healthy
- American Society of Anesthesiologists(ASA) class1 and 2
- Women undergoing non-elective caesarean section whose anesthetic plan is for spinal anesthesia with bupivacaine and fentanyl
Who cannot join
- • Women with American society of anesthesiologist physical status>2
- Body mass index >or =40 kg per square meter
- Height <150 cm
- Any contraindication to the spinal anesthesia
- History of substance abuse
- History of hallucinations
Show all 10Show fewer
- Chronic opioid therapy
- Chronic pain or on any pain medication currently
- Patient with maternal complications,like cardiovascular disease pre-eclampsia,diabetes,multiple gestation,known fetal abnormality
- Cases with severely compromised fetus where immediate administration of general anesthesia is required.
Trial locations and contacts
1 site in 1 country.
Nepal1 site
BP Koirala Institute of Health Sciences (BPKIHS)
Dharān, Koshi, 56700
About this study
This randomized double blind study will be conducted in pregnant woman planned for non elective cesarean section under spinal anesthesia. Ketamine group will receive intravenous 0.25 mg/kg and placebo group will receive same amount of normal saline after spinal anesthesia prior to skin incision. Postoperative outcomes measures are total opioid consumption and pain scores for 24 hrs.
- Being tested
- Ketamine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called ketamine hydrochloride
the analgesic affects of ketamine will be compared between the experimental and placebo group.
PlaceboDrug
the analgesic requirement will be calculated in placebo group.
| Study group | Role | What they receive |
|---|---|---|
| analgesic effects of ketamine | Experimental | the experimental group will receive ketamine intravenously at 0.25 mg per kg before skin incision. Receives: Drug: Ketamine |
| placebo | Placebo comparator | they will receive same volume of 0.9% normal saline as calculated for experimental group before skin incision. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid requirement postoperatively
Total opioid required up to 24 postoperatively in ketamine and placebo group.
Measured: 24 hrs
Secondary outcomes (3)
Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative )
- Postoperative NRS Scores (on arrival to Post operative care unit), 2, 4, 6, 8, 12 and 24 h ).The NRS ranges from 0- 10 and 0 refers to no pain and 10 means extreme possible pain perceived.
Measured: 24 hrs
Time to first perception of pain
Time to first perception of pain
Measured: 24 hrs
Incidence of side effects
Incidence of post operative nausea and vomiting, shivering, sedation scores, side effects related to ketamine during the first 24h
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Apr 2018
- Primary completion7 Mar 2019
- Study completion7 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Elective Cesarean Section and Ketamine AnalgesiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prahlad adhikari, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450499
- Sponsor's protocol ID
- IRC/1089/017
- Status last verified
- Aug 2019
- First submitted
- 18 Feb 2018
- Last updated
- 20 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adhikari P, Subedi A, Sah BP, Pokharel K. Analgesic effects of intravenous ketamine after spinal anaesthesia for non-elective caesarean delivery: a randomised controlled trial. BMJ Open. 2021 Jun 30;11(6):e044168. doi: 10.1136/bmjopen-2020-044168.
PubMed 34193480
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section
- ClinicalTrials.gov ID
- NCT03450499
- Acronym / sponsor ID
- IRC/1089/017
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 1 Mar 2018 (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.
This randomized double blind study will be conducted in pregnant woman planned for non elective cesarean section under spinal anesthesia. Ketamine group will receive intravenous 0.25 mg/kg and placebo group will receive same amount of normal saline after spinal anesthesia prior to skin incision. Postoperative outcomes measures are total opioid consumption and pain scores for 24 hrs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| analgesic effects of ketamine | Experimental | Drug: Ketaminethe experimental group will receive ketamine intravenously at 0.25 mg per kg before skin incision. |
| placebo | Placebo comparator | Drug: Placebothey will receive same volume of 0.9% normal saline as calculated for experimental group before skin incision. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • All women at term(>or =37 weeks of gestation)
Key exclusion criteria (10 listed)
- • Women with American society of anesthesiologist physical status>2
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 |
|---|---|---|
| KetamineAlso: ketamine hydrochloridethe analgesic affects of ketamine will be compared between the experimental and placebo group. | Drug | analgesic effects of ketamine |
| Placebothe analgesic requirement will be calculated in placebo group. | Drug | placebo |
Primary outcome
Total opioid requirement postoperatively
Time frame: 24 hrs
Total opioid required up to 24 postoperatively in ketamine and placebo group.
3 secondary outcomes
Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative )
Time frame: 24 hrs
Time to first perception of pain
Time frame: 24 hrs
Incidence of side effects
Time frame: 24 hrs
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 20 Aug 2019.
- Derived from this study: PubMed 34193480Adhikari P, Subedi A, Sah BP, Pokharel K. Analgesic effects of intravenous ketamine after spinal anaesthesia for non-elective caesarean delivery: a randomised controlled trial. BMJ Open. 2021 Jun 30;11(6):e044168. doi: 10.1136/bmjopen-2020-044168.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine in people with Non Elective Cesarean Section and Ketamine Analgesia, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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 4 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: finished, as of the sponsor's last update on 20 Aug 2019. 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 Nepal. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Total opioid requirement postoperatively (time frame: 24 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03450499, which also lists 1 linked publication.
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 20 Aug 2019.