Quality of RecoveryPhase 4NCT03724019
Impact of the Use of Ketamine in Laparoscopic Surgery.
A Phase 4 study testing Ketamine in people with Quality of Recovery, run by Universidade do Porto at 1 site in Portugal.
Trial summary
In order to improve the postoperative period (namely pain control), several drugs can be used. For instance, ketamine is a general anesthetic that holds strong analgesic properties, yet also owns undesirable effects, in which hallucination phenomena is one the most common indicator. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Recovery
- What is being tested?
- Ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2018to 1 Apr 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 18 and 65 years age, with an American Society of Anesthesiology physical status I, II or III.
- Laparoscopic surgery (sleeve gastrectomy, salpingectomy, or cholecystectomy)
Who cannot join
- patient refusal, the incapacity of providing informed consent, drug abusers (current or past history) or alcohol abuse, medication with benzodiazepines, inability to give informed consent, pregnant, emergency surgery, psychiatric pathology, existence of surgical complications in the recovery and admission to a level II or III unit ( for any reason).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of the Use of Ketamine in Laparoscopic Surgery, Using the Quality of Recovery 15 Questionnaire.
In order to improve the postoperative period (namely pain control), several drugs can be used. For instance, ketamine is a general anesthetic that holds strong analgesic properties, yet also owns undesirable effects, in which hallucination phenomena is one the most common indicator. However, slight information is available about the real implication in the quality of the recovery on the use of ketamine for postoperative pain treatment. The quality of the recovery includes several health conditions, such as pain, physical comfort, physical independence, psychological support and emotional state. In recent years, investigations in this field has been attracted the attention by the health professionals, since is an indicator of the quality of post-operative care. To evaluate these parameters, questionnaires have been developed, in which the Portuguese version of Quality of Recovery 15 (QoR-15) is include. This questionnaire evaluates five psychometric dimensions. Therefore, the present study has the main goal, the evaluation of the effect of using ketamine in laparoscopic surgery and the quality of the recovery using the QoR-15 questionnaire.
- Conditions
- Quality of Recovery
- Being tested
- Ketamine
- Keywords
- Ketamine, QoR-15, Laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Administration of 0.5mg / kg ideal body weight of ketamine at induction of anesthesia in laparoscopic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group Q | Experimental | 20 milliliter of ketamine (0.5mg / kg ideal body weight) at induction of anesthesia. Receives: Drug: Ketamine |
| Group S | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact in QoR-15 score
Difference (improvement or worsening) in the postoperative baseline score (preoperative) in the Portuguese version of the Quality of Recovery questionnaire 15.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Oct 2018
- Primary completion1 Oct 2022
- Study completion1 Apr 2023
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 Quality of RecoveryStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724019
- Sponsor's protocol ID
- QuetaminaQOR15
- Status last verified
- Sep 2022
- First submitted
- 26 Oct 2018
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Pereira H, Graca MI, Fonseca D, Mendes-Castro A, Abelha F. Impact of Ketamine on Quality of Recovery after Laparoscopic Surgery: A Single-Centre Single-Blinded Trial Using the QoR-15 Questionnaire. Anesthesiol Res Pract. 2023 Jan 20;2023:8890025. doi: 10.1155/2023/8890025. eCollection 2023.
PubMed 36714040
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the Use of Ketamine in Laparoscopic Surgery, Using the Quality of Recovery 15 Questionnaire.
- ClinicalTrials.gov ID
- NCT03724019
- Acronym / sponsor ID
- QuetaminaQOR15
- Conditions
- Quality of Recovery
- Keywords
- Ketamine, QoR-15, Laparoscopic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 30 Oct 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.
In order to improve the postoperative period (namely pain control), several drugs can be used. For instance, ketamine is a general anesthetic that holds strong analgesic properties, yet also owns undesirable effects, in which hallucination phenomena is one the most common indicator. However, slight information is available about the real implication in the quality of the recovery on the use of ketamine for postoperative pain treatment. The quality of the recovery includes several health conditions, such as pain, physical comfort, physical independence, psychological support and emotional state. In recent years, investigations in this field has been attracted the attention by the health professionals, since is an indicator of the quality of post-operative care. To evaluate these parameters, questionnaires have been developed, in which the Portuguese version of Quality of Recovery 15 (QoR-15) is include. This questionnaire evaluates five psychometric dimensions. Therefore, the present study has the main goal, the evaluation of the effect of using ketamine in laparoscopic surgery and the quality of the recovery using the QoR-15 questionnaire.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Q | Experimental | Drug: Ketamine20 milliliter of ketamine (0.5mg / kg ideal body weight) at induction of anesthesia. |
| Group S | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between 18 and 65 years age, with an American Society of Anesthesiology physical status I, II or III.
- Laparoscopic surgery (sleeve gastrectomy, salpingectomy, or cholecystectomy)
Key exclusion criteria (1 listed)
- patient refusal, the incapacity of providing informed consent, drug abusers (current or past history) or alcohol abuse, medication with benzodiazepines, inability to give informed consent, pregnant, emergency surgery, psychiatric pathology, existence of surgical complications in the recovery and admission to a level II or III unit ( for any reason).
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 |
|---|---|---|
| KetamineAdministration of 0.5mg / kg ideal body weight of ketamine at induction of anesthesia in laparoscopic surgery. | Drug | Group Q |
Primary outcome
Impact in QoR-15 score
Time frame: 6 months
Difference (improvement or worsening) in the postoperative baseline score (preoperative) in the Portuguese version of the Quality of Recovery questionnaire 15.
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 10 May 2023.
- Derived from this study: PubMed 36714040Pereira H, Graca MI, Fonseca D, Mendes-Castro A, Abelha F. Impact of Ketamine on Quality of Recovery after Laparoscopic Surgery: A Single-Centre Single-Blinded Trial Using the QoR-15 Questionnaire. Anesthesiol Res Pract. 2023 Jan 20;2023:8890025. doi: 10.1155/2023/8890025. eCollection 2023.
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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.
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 Quality of Recovery, run by Universidade do Porto at 1 site in Portugal.
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 2 inclusion and 1 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 10 May 2023. 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 Portugal. 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. 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?
Impact in QoR-15 score (time frame: 6 months). 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 NCT03724019, 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 10 May 2023.