Fractures, BonePhase 4NCT03035942
Quality of Recovery After Dexamethasone, Ondansetron or Placebo Intrathecal Morphine Administration
A Phase 4 study testing Dexamethasone, Ondansetron and Saline in people with Fractures, Bone and Nausea and Vomiting, Postoperative, run by Pontificia Universidade Catolica de Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate not only the occurrence of side effects, but the quality of the recovery (QoR-40 Questionnaire) of patients submitted to spinal anesthesia with administration of low doses (0.1 mg) of intrathecal morphine for the surgical treatment of fractures in one of the lower limbs and who… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fractures, Bone, Nausea and Vomiting, Postoperative, Pruritus
- What is being tested?
- Dexamethasone, Ondansetron and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2017to 4 Nov 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I or II, who will scheduled to undergo surgical treatment of lower limb fractures
Who cannot join
- Patients who:
- refused to participate in the study;
- were not able to communicate due to alterations in the level of consciousness, or neurologic, or psychiatric disease;
- presented with contraindication to any of the drugs used in the present study;
- had history of alcohol or drug abuse and
- had surgery in the last 10 days were excluded.
- Reasons for exclusion after randomisation will be protocol violations or if the anesthesia technique was changed from a spinal to a general approach.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Dexamethasone or Ondansetron in the Quality of Recovery After Intrathecal Morphine Administration in Patients Undergoing Lower Limb Surgery.
The aim of this study is to evaluate not only the occurrence of side effects, but the quality of the recovery (QoR-40 Questionnaire) of patients submitted to spinal anesthesia with administration of low doses (0.1 mg) of intrathecal morphine for the surgical treatment of fractures in one of the lower limbs and who will receive prophylactic ondansetron (4mg), dexamethasone (8mg) or placebo.
Read the detailed description
This randomised, double-blinded trial was approved by the Research Ethics Committee of the School of Medical and Health Sciences, Pontifical Catholic University of São Paulo (Sorocaba, São Paulo - Brazil), on June 14 2016, CAAE (Presentation Certificate for Ethical Appreciation) 58208015.7.0000.5373 (Chairperson Prof. J.A. Costa). On the day of surgery, after completion of the pre-anesthetic evaluation and due explanations of the study, consent will be obtained. No participant will take any pre-anesthetic medication before surgery. Subjects will be randomised using a computer-generated (www.random.org) table of random numbers into 3 groups: S (saline), D (dexamethasone 8 mg), or O (ondansetron 4 mg). Group assignments will be sealed in sequentially numbered opaque envelopes that were opened after patient inclusion in the study. All care providers, researchers, and patients will be blinded to group assignments. Study 5-mL syringes will be prepared by a nurse independent of the study. Normal saline (5 mL total volume), dexamethasone (made up to 5 mL with normal saline), or ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened.
After arrival in the operating room, standard ASA (American Society of Anesthesiologists) monitors will be applied. Immediately after venoclysis,e.v. midazolam will be administered as titrated doses to achieve 3 or 4 on Ramsay scale. Spinal puncture will be performed with the patient in the seated position in the median or paramedian line at L3-L4 or L2-L3 interspace using a 26-gauge Quincke needle. Anesthesia will be established with a single bolus of 0.5% hyperbaric bupivacaine (17.5 mg if ≥ 70 kg or expected surgery duration > 150 minutes and 15 mg if < 70 kg) and preservative-free morphine 0.1 mg. Normal saline will be used for fluid replacement therapy. In case of failure of spinal anesthesia, the technique will be repeated or a general approach will be performed and the patient will be excluded from the study. Titrated doses of midazolam (up to 10 mg) or propofol continuous infusion will be administered to achieve perioperative sedation (≥4 on Ramsay scale). Supplemental oxygen 5 L/min via a vent mask will be administered during and after surgery.
Postanesthesia care unit (PACU) All patients will be transferred to the PACU. Data related to the occurrence of pain, nausea, vomiting, pruritus, urinary retention and time to Aldrete score ≥ 9 at the PACU will be recorded. Pain will be assessed every 15 minutes using a 0-10 numeric pain rating scale (NRS), where zero meant no pain and 10 the worst imaginable pain. Morphine (1 to 2 mg) was administered intravenously every 10 minutes to maintain the pain score below 4 (1 mg when the pain score was <7 and 2 mg when it was ≥7). Postoperative nausea and vomiting (PONV) will be treated with dimenhydrinate (30 mg) intravenously. Pruritus will be classified as follow: 0 - no symptoms, 1 - 3 - mild symptoms, 3 - 7 moderate symptoms and 7 - 10 - severe symptoms. Nalbuphine 5 mg intravenously will be administered when score > 4.
Ward Following discharge from the PACU (minimum stay 60 minutes and Aldrete score ≥ 9), all of the participants were given ketoprofen (100 mg) every 12 hours and dipyrone (30 mg.kg-1, maximum 1 g) every six hours intravenously. Whenever patients judged that their analgesia was insufficient, tramadol (100 mg) was administered intravenously at eight-hour minimum intervals as needed. Postoperative nausea and vomiting (PONV) were treated with dimenhydrinate (30 mg) intravenously. An investigator who was blinded to group assignment collected all postoperative outcome data 24 hours after surgical procedure. Subjects were asked to rate the higher score of pain (NRS) during the hospital ward stay. Tramadol consumption, occurrence of urinary retention and the number of nausea and vomiting episodes were also recorded. These findings were confirmed with the ward nursing staff. All subjects stayed at hospital for at least 24 hours.
Data Collection The baseline QoR-40 questionnaire was completed by the subjects after informed consent was obtained in the preoperative holding area and 24 hours after surgery by a blinded investigator. The QoR-40 questionnaire evaluates five dimensions of recovery (physical comfort - 12 items; emotional state - 7 items; physical independence - 5 items; physiological support - 7 items; and pain - 7 items). Each item was rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR-40 ranges from 40 (very poor quality of recovery) to 200 (best quality of recovery).
The primary outcome of interest will be the QoR-40 score on postoperative day 1 (POD1).
- Conditions
- Fractures, Bone, Nausea and Vomiting, Postoperative, Pruritus, Morphine Adverse Reaction, Satisfaction, Personal
- Being tested
- Dexamethasone, Ondansetron, Saline
- Keywords
- Intrathecal morphine, Nausea and vomiting, Quality of recovery, Patient satisfaction, Pruritus, Postoperative pain
- Medical subject headings
- Fractures, Bone, Postoperative Nausea and Vomiting, Pruritus, Personal Satisfaction, Nausea, Vomiting, Patient Satisfaction, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called D Group
Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
OndansetronDrug
Also called O Group
Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
SalineDrug
Also called Placebo Group
Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
| Study group | Role | What they receive |
|---|---|---|
| D Group | Experimental | Dexamethasone 8 mg Receives: Drug: Dexamethasone |
| O group | Experimental | Ondansetron 4 mg Receives: Drug: Ondansetron |
| S group | Placebo comparator | Normal saline (5 mL total volume) Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
Quality of Recovery Questionnaire (QoR-40). Minimum score 40 (very poor quality of recovery) and maximun score 200 (excellent quality of recovery). Higher scores mean better outcome
Measured: Twenty four hours after surgery by a blinded investigator
Secondary outcomes (3)
Nausea and Vomiting During PACU Staying
The occurrence of PONV will be registered during the PACU
Measured: 4h
Number of Participants With Pruritus
The occurrence of localized or generalized itching (patients who answered yes or no)
Measured: 24 hours
Pain During Postanesthesia Care Unit and Ward Stay (Numeric Rating Scale - NRS)
Pain were assessed every 15 minutes during postanesthesia care unit, where zero meant no pain and 10 the worst imaginable pain (higher values represent worse outcome). Twenty four hours after surgery, patients were asked to describe the highest pain score (NRS) during ward stay.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start2 Jan 2017
- Primary completion1 Oct 2018
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Fractures, BoneStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, double-blinded
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Catolica de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Toshiyuki Moro, Pontificia Universidade Catolica de Sao Paulo
- Investigators
- Eduardo T Moro, Professor, Principal investigator, PUC São Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035942
- Sponsor's protocol ID
- PUCSP 1863886
- Status last verified
- Jan 2020
- First submitted
- 26 Jan 2017
- Last updated
- 19 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacobson L, Chabal C, Brody MC, Ward RJ, Wasse L. Intrathecal methadone: a dose-response study and comparison with intrathecal morphine 0.5 mg. Pain. 1990 Nov;43(2):141-148. doi: 10.1016/0304-3959(90)91066-R.
PubMed 2087326Slappendel R, Weber EW, Dirksen R, Gielen MJ, van Limbeek J. Optimization of the dose of intrathecal morphine in total hip surgery: a dose-finding study. Anesth Analg. 1999 Apr;88(4):822-6. doi: 10.1097/00000539-199904000-00026.
PubMed 10195531Koju RB, Gurung BS, Dongol Y. Prophylactic administration of ondansetron in prevention of intrathecal morphine-induced pruritus and post-operative nausea and vomiting in patients undergoing caesarean section. BMC Anesthesiol. 2015 Feb 17;15:18. doi: 10.1186/1471-2253-15-18.
PubMed 25971957Braga AA, Frias JA, Braga FS, Poterio GB, Hirata ES, Torres NA. Spinal anesthesia for cesarean section. Use of hyperbaric bupivacaine (10mg) combined with different adjuvants. Rev Bras Anestesiol. 2012 Nov-Dec;62(6):775-87. doi: 10.1016/S0034-7094(12)70178-2.
PubMed 23176986Krajnik M, Zylicz Z. Understanding pruritus in systemic disease. J Pain Symptom Manage. 2001 Feb;21(2):151-68. doi: 10.1016/s0885-3924(00)00256-6.
PubMed 11226766Griffiths JD, Gyte GM, Paranjothy S, Brown HC, Broughton HK, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007579. doi: 10.1002/14651858.CD007579.pub2.
PubMed 22972112Wu JI, Lo Y, Chia YY, Liu K, Fong WP, Yang LC, Tan PH. Prevention of postoperative nausea and vomiting after intrathecal morphine for Cesarean section: a randomized comparison of dexamethasone, droperidol, and a combination. Int J Obstet Anesth. 2007 Apr;16(2):122-7. doi: 10.1016/j.ijoa.2006.11.004. Epub 2007 Feb 1.
PubMed 17275282Szarvas S, Chellapuri RS, Harmon DC, Owens J, Murphy D, Shorten GD. A comparison of dexamethasone, ondansetron, and dexamethasone plus ondansetron as prophylactic antiemetic and antipruritic therapy in patients receiving intrathecal morphine for major orthopedic surgery. Anesth Analg. 2003 Jul;97(1):259-63, table of contents. doi: 10.1213/01.ane.0000066310.49139.2a.
PubMed 12818978Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
PubMed 10740540
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dexamethasone or Ondansetron in the Quality of Recovery After Intrathecal Morphine Administration in Patients Undergoing Lower Limb Surgery.
- ClinicalTrials.gov ID
- NCT03035942
- Acronym / sponsor ID
- PUCSP 1863886
- Conditions
- Fractures, Bone, Nausea and Vomiting, Postoperative, Pruritus, Morphine Adverse Reaction, Satisfaction, Personal
- Keywords
- Intrathecal morphine, Nausea and vomiting, Quality of recovery, Patient satisfaction, Pruritus, Postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Pontificia Universidade Catolica de Sao PauloUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 19 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate not only the occurrence of side effects, but the quality of the recovery (QoR-40 Questionnaire) of patients submitted to spinal anesthesia with administration of low doses (0.1 mg) of intrathecal morphine for the surgical treatment of fractures in one of the lower limbs and who will receive prophylactic ondansetron (4mg), dexamethasone (8mg) or placebo.
Detailed description
This randomised, double-blinded trial was approved by the Research Ethics Committee of the School of Medical and Health Sciences, Pontifical Catholic University of São Paulo (Sorocaba, São Paulo - Brazil), on June 14 2016, CAAE (Presentation Certificate for Ethical Appreciation) 58208015.7.0000.5373 (Chairperson Prof. J.A. Costa). On the day of surgery, after completion of the pre-anesthetic evaluation and due explanations of the study, consent will be obtained. No participant will take any pre-anesthetic medication before surgery. Subjects will be randomised using a computer-generated (www.random.org) table of random numbers into 3 groups: S (saline), D (dexamethasone 8 mg), or O (ondansetron 4 mg). Group assignments will be sealed in sequentially numbered opaque envelopes that were opened after patient inclusion in the study. All care providers, researchers, and patients will be blinded to group assignments. Study 5-mL syringes will be prepared by a nurse independent of the study. Normal saline (5 mL total volume), dexamethasone (made up to 5 mL with normal saline), or ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened.
After arrival in the operating room, standard ASA (American Society of Anesthesiologists) monitors will be applied. Immediately after venoclysis,e.v. midazolam will be administered as titrated doses to achieve 3 or 4 on Ramsay scale. Spinal puncture will be performed with the patient in the seated position in the median or paramedian line at L3-L4 or L2-L3 interspace using a 26-gauge Quincke needle. Anesthesia will be established with a single bolus of 0.5% hyperbaric bupivacaine (17.5 mg if ≥ 70 kg or expected surgery duration > 150 minutes and 15 mg if < 70 kg) and preservative-free morphine 0.1 mg. Normal saline will be used for fluid replacement therapy. In case of failure of spinal anesthesia, the technique will be repeated or a general approach will be performed and the patient will be excluded from the study. Titrated doses of midazolam (up to 10 mg) or propofol continuous infusion will be administered to achieve perioperative sedation (≥4 on Ramsay scale). Supplemental oxygen 5 L/min via a vent mask will be administered during and after surgery.
Postanesthesia care unit (PACU) All patients will be transferred to the PACU. Data related to the occurrence of pain, nausea, vomiting, pruritus, urinary retention and time to Aldrete score ≥ 9 at the PACU will be recorded. Pain will be assessed every 15 minutes using a 0-10 numeric pain rating scale (NRS), where zero meant no pain and 10 the worst imaginable pain. Morphine (1 to 2 mg) was administered intravenously every 10 minutes to maintain the pain score below 4 (1 mg when the pain score was <7 and 2 mg when it was ≥7). Postoperative nausea and vomiting (PONV) will be treated with dimenhydrinate (30 mg) intravenously. Pruritus will be classified as follow: 0 - no symptoms, 1 - 3 - mild symptoms, 3 - 7 moderate symptoms and 7 - 10 - severe symptoms. Nalbuphine 5 mg intravenously will be administered when score > 4.
Ward Following discharge from the PACU (minimum stay 60 minutes and Aldrete score ≥ 9), all of the participants were given ketoprofen (100 mg) every 12 hours and dipyrone (30 mg.kg-1, maximum 1 g) every six hours intravenously. Whenever patients judged that their analgesia was insufficient, tramadol (100 mg) was administered intravenously at eight-hour minimum intervals as needed. Postoperative nausea and vomiting (PONV) were treated with dimenhydrinate (30 mg) intravenously. An investigator who was blinded to group assignment collected all postoperative outcome data 24 hours after surgical procedure. Subjects were asked to rate the higher score of pain (NRS) during the hospital ward stay. Tramadol consumption, occurrence of urinary retention and the number of nausea and vomiting episodes were also recorded. These findings were confirmed with the ward nursing staff. All subjects stayed at hospital for at least 24 hours.
Data Collection The baseline QoR-40 questionnaire was completed by the subjects after informed consent was obtained in the preoperative holding area and 24 hours after surgery by a blinded investigator. The QoR-40 questionnaire evaluates five dimensions of recovery (physical comfort - 12 items; emotional state - 7 items; physical independence - 5 items; physiological support - 7 items; and pain - 7 items). Each item was rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR-40 ranges from 40 (very poor quality of recovery) to 200 (best quality of recovery).
The primary outcome of interest will be the QoR-40 score on postoperative day 1 (POD1).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized, controlled, double-blinded
| Arm | Type | Receives |
|---|---|---|
| D Group | Experimental | Drug: DexamethasoneDexamethasone 8 mg |
| O group | Experimental | Drug: OndansetronOndansetron 4 mg |
| S group | Placebo comparator | Drug: SalineNormal saline (5 mL total volume) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I or II, who will scheduled to undergo surgical treatment of lower limb fractures
Key exclusion criteria (7 listed)
- refused to participate in the study;
- were not able to communicate due to alterations in the level of consciousness, or neurologic, or psychiatric disease;
- presented with contraindication to any of the drugs used in the present study;
- had history of alcohol or drug abuse and
- had surgery in the last 10 days were excluded.
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 |
|---|---|---|
| DexamethasoneAlso: D GroupDexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed. | Drug | D Group |
| OndansetronAlso: O GroupOndansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed. | Drug | O group |
| SalineAlso: Placebo GroupNormal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed. | Drug | S group |
Primary outcome
Quality of Recovery
Time frame: Twenty four hours after surgery by a blinded investigator
Quality of Recovery Questionnaire (QoR-40). Minimum score 40 (very poor quality of recovery) and maximun score 200 (excellent quality of recovery). Higher scores mean better outcome
3 secondary outcomes
Nausea and Vomiting During PACU Staying
Time frame: 4h
Number of Participants With Pruritus
Time frame: 24 hours
Pain During Postanesthesia Care Unit and Ward Stay (Numeric Rating Scale - NRS)
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2087326Jacobson L, Chabal C, Brody MC, Ward RJ, Wasse L. Intrathecal methadone: a dose-response study and comparison with intrathecal morphine 0.5 mg. Pain. 1990 Nov;43(2):141-148. doi: 10.1016/0304-3959(90)91066-R.
- Background: PubMed 10195531Slappendel R, Weber EW, Dirksen R, Gielen MJ, van Limbeek J. Optimization of the dose of intrathecal morphine in total hip surgery: a dose-finding study. Anesth Analg. 1999 Apr;88(4):822-6. doi: 10.1097/00000539-199904000-00026.
- Background: PubMed 25971957Koju RB, Gurung BS, Dongol Y. Prophylactic administration of ondansetron in prevention of intrathecal morphine-induced pruritus and post-operative nausea and vomiting in patients undergoing caesarean section. BMC Anesthesiol. 2015 Feb 17;15:18. doi: 10.1186/1471-2253-15-18.
- Background: PubMed 23176986Braga AA, Frias JA, Braga FS, Poterio GB, Hirata ES, Torres NA. Spinal anesthesia for cesarean section. Use of hyperbaric bupivacaine (10mg) combined with different adjuvants. Rev Bras Anestesiol. 2012 Nov-Dec;62(6):775-87. doi: 10.1016/S0034-7094(12)70178-2.
- Background: PubMed 11226766Krajnik M, Zylicz Z. Understanding pruritus in systemic disease. J Pain Symptom Manage. 2001 Feb;21(2):151-68. doi: 10.1016/s0885-3924(00)00256-6.
- Background: PubMed 22972112Griffiths JD, Gyte GM, Paranjothy S, Brown HC, Broughton HK, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007579. doi: 10.1002/14651858.CD007579.pub2.
- Background: PubMed 17275282Wu JI, Lo Y, Chia YY, Liu K, Fong WP, Yang LC, Tan PH. Prevention of postoperative nausea and vomiting after intrathecal morphine for Cesarean section: a randomized comparison of dexamethasone, droperidol, and a combination. Int J Obstet Anesth. 2007 Apr;16(2):122-7. doi: 10.1016/j.ijoa.2006.11.004. Epub 2007 Feb 1.
- Background: PubMed 12818978Szarvas S, Chellapuri RS, Harmon DC, Owens J, Murphy D, Shorten GD. A comparison of dexamethasone, ondansetron, and dexamethasone plus ondansetron as prophylactic antiemetic and antipruritic therapy in patients receiving intrathecal morphine for major orthopedic surgery. Anesth Analg. 2003 Jul;97(1):259-63, table of contents. doi: 10.1213/01.ane.0000066310.49139.2a.
- Background: PubMed 10740540Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
- 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.
Eduardo T Moro, Professor principal investigator
PUC São Paulo University
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 Dexamethasone, Ondansetron and Saline in people with Fractures, Bone and Nausea and Vomiting, Postoperative, run by Pontificia Universidade Catolica de Sao Paulo at 1 site in Brazil.
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 7 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 19 Mar 2020. 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 Brazil. 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?
Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quality of Recovery (time frame: Twenty four hours after surgery by a blinded investigator). 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 NCT03035942, which also lists 9 linked publications.
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 19 Mar 2020.