Nausea and Vomiting, PostoperativePhase 4NCT06410365
Impact of Intrathecal vs Intravenous Dexmedetomidine
A Phase 4 study testing Dexmedetomidine injection in people with Nausea and Vomiting, Postoperative, run by Muhammad Ilyas.
Trial summary
The purpose of this research is to evaluate the impact of intrathecal dexmedetomidine in comparison with intravenous route in patients undergoing cesarean section. Alternate hypothesis :Dexmedetomidine is more effective when given intrathecally as adjuvant to bupivacaine in elective cesarean section Null Hypothesis… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nausea and Vomiting, Postoperative
- What is being tested?
- Dexmedetomidine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 31 Dec 2024
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women between ages 18-35 years
- Belongs to ASA class I or II
- Subjected to elective C-section
Who cannot join
- Any history of gastrointestinal disease diabetes, thyroid disease, hypertension, obesity, or anaemia
- History of alcohol or drug abuse;
- Major complications of pregnancy
- Patients have contraindication to spinal block or allergic to any of drug
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Intrathecal Versus Intravenous Dexmedetomidine Adjuvant to Bupivacaine in Elective Cesarian Section
The purpose of this research is to evaluate the impact of intrathecal dexmedetomidine in comparison with intravenous route in patients undergoing cesarean section.
Alternate hypothesis :Dexmedetomidine is more effective when given intrathecally as adjuvant to bupivacaine in elective cesarean section Null Hypothesis: Dexmedetomidine is more effective when given intravenously as adjuvant to bupivacaine in elective cesarean section Study Design: Randomized controlled trial Study setting: Watim General Hospital Study Duration: 18 months after synopsis approval Sampling technique: Simple random sampling Sample Size: Using the Open Epi program, a sample size of 60 patients (30 in each group) was determined with a 95% confidence interval and 80% power.
Read more
Inclusion Criteria:
- Pregnant women between ages 18-35 years
- Belongs to ASA class I or II
- Subjected to elective C-section
Exclusion Criteria:
- Any history of gastrointestinal disease diabetes, thyroid disease, hypertension, obesity, or anemia
- History of alcohol or drug abuse;
- Major complications of pregnancy
- Patients have contraindication to spinal block or allergic to any of drug
Read the detailed description
Introduction Cesarean section under spinal anesthesia has gained worldwide popularity in the past two, three decades as it provides quick, intense and balanced anesthesia. Patients may avoid the dangers of general anesthesia by having a cesarean section while still receiving anesthetic and pain relief via spinal anesthesia Patients still experience problems during surgical operations due to adverse effects produced by spinal anesthesia, such as nausea, vomiting and shivering, even though the risk is lower than that of general anesthetic One research estimates that as many as 55 percent of people shiver at some point throughout their lives .There may be adverse consequences on heart rate, oxygen saturation, and blood pressure from excessive shivering. Cardiopulmonary insufficiency increases the risk for potentially fatal side effects While there has been much research on nausea and vomiting after epidural anesthesia, less attention has been paid to IONV during the procedure itself Patients' comfort is diminished, hospital stays are prolonged, and more expenses are incurred when nausea and vomiting occur during surgery and remain thereafter. Considerable attention should be paid to this issue because of the seriousness of its potential outcomes, which include, among others, dehydration, electrolyte imbalance, wound dehiscence, venous hypertension and bleeding, esophageal rupture, airway obstruction, and aspiration pneumonia. In several types of surgeries, patients often have nausea and vomiting afterward However, caesarean sections performed with regional anesthesia have this issue more often . There are several factors that might put a patient at risk for IONV, including increased intragastric pressure, hypotension, extending the peritoneum (exteriorization of the uterus), extensive surgical manipulation and visceral stimulation, the use of opioids, the use of uterotonic drugs, and the patient's mental health. The hypotension that occurs during spinal, epidural, or spinal-epidural (combined) anesthesia is a major risk factor for ischemic optic neuropathy of the visual system. Procedure-specific factors that may lead to IONV include peritonealization, exteriorizing the uterus for suturing, and peritoneal cleaning IONV has an estimated 80 percent prevalence. As a result, preventative medicine is essential . Treatment rather than prevention has been the primary focus of previous IONV research. It seems that IONV may be improved by using a combination of preoperative and intraoperative midazolam and propofol, closely monitoring hypotension, attaining a good anesthetic block, doing surgery gently, and using uterotonic drugs sparingly.
Postoperative pain is still a major problem in healthcare all around the world, despite developments in anesthesiology and surgical methods. Poor pain management after surgery is linked to several unfavorable results, including patient dissatisfaction, low quality of life, slowed healing, and increasing reliance on drugs . Intrathecal block is the most popular method for anesthetizing patients undergoing C-sections, which is the most frequent surgical operation for women of childbearing age. Increased protection for both mother and child, a strong motor and sensory block, a low failure rate, and a reasonable price tag are just a few of the benefits it provides. Subarachnoid block, when done just with local anesthetics, has the fundamental drawback of providing only temporary relief from postoperative pain due to its limited duration of action. Adjuvants are often used to enhance the duration of analgesia by enhancing the quality of the block and lengthening the duration of analgesia . Intrathecally administering dexmedetomidine, a highly selective alpha-2 agonist, in combination with hyperbaric bupivacaine results in a much longer duration of analgesia and an improved safety profile .Studies on full-term patients having spinal anesthesia for elective caesarean sections indicated that the combination of Dexmedetomidine and bupivacaine was just as effective as morphine and bupivacaine for maintaining pain relief for a longer period of time showed that among ASA I or II patients undergoing caesarean delivery, the duration of analgesia produced by bupivacaine + Dexmedetomidine was significantly longer than the length provided by bupivacaine + placebo. Dexmedetomidine patients also had considerably decreased postoperative rescued sufentanil intake compared to those in the control group.
We expect that the addition of dexmedetomidine as an adjuvant to intrathecal hyperbaric bupivacaine would enhance intraoperative blockade conditions during cesarean section, extend postoperative sensory block, reduce nausea vomiting and shivering without affecting the motor block and with minimal additional adverse effects.
Data Collection:
Participant's demographic and clinical information will be obtained through a questionnaire and the patient will be randomly divided into two groups using lottery method. Participants in Group A will receive an intravenous dose of dexmedetomidine diluted in 20 milliliters of saline, with 1 milliliter withdrawn from a 2-milliliter syringe. Group B will receive intravenously one milliliter of 0.9% isotonic saline in a two milliliter syringe. The participant will be given a subarachnoid block in accordance with standard operating procedure. Group A will receive intrathecal 0.75% bupivacaine (1.2ml +1 ml N/S) and group B will receive intrathecal bupivacaine 0.75%(1.2ml+plus 5 μg Dex (diluted in N/S up to the volume of 1 ml intrathecally. T4-5 block will be achieved by turning the patient supine with left uterine displacement. . Intraoperative nausea and vomiting will be assessed using a a 4-point scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe) Postoperative pain will measured using a numeric pain rating scale (0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain) every 30 minutes in the postoperative care unit until the patient demanded their first analgesic dose, which will serve as the study's cut-off point. Injectable Ketorolac 30 mg will be used as a rescue analgesic
Data Analysis:
SPSS-23 will be used for the statistical analysis of the data. The duration of post-operative analgesia will be compared between the two groups using an independent sample t-test. Using stratification, we will be able to regulate potential confounding variables. To compare how long patients needed pain relief after surgery among groups, an independent samples t-test will be used after stratification. The cutoff for significance will be set at P≤0.05.
- Conditions
- Nausea and Vomiting, Postoperative
- Being tested
- Dexmedetomidine injection
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine injectionDrug
Also called Bupivacaine
Comparison of intravenous and intrathecal route of dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| intrathecal dexmedetomidine+ bupivacaine | Experimental | intrathecal bupivacaine 0.75%(1.2ml+plus 5 μg Dex (diluted in N/S up to the volume of 1 ml intrathecally once Receives: Drug: Dexmedetomidine injection |
| intravenous dexmedetomidine+ bupivacane | Experimental | intravenous dexmedetomidine 1mcg/kg in normal saline + intrathecal .75% bupivacaine (1.2ml) Receives: Drug: Dexmedetomidine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of clinical efficacy of intrathecal versus intravenous dexmedetomidine on intraoperative nausea vomiting,shivering and postoperative pain
Intraoperative nausea and vomiting will be assessed using a a 4-point scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe) Postoperative pain will measured using a numeric pain rating scale (0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain) every 30 minutes in the postoperative care
Measured: during cesarean section surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nausea and Vomiting, PostoperativeStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad Ilyas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Ilyas, Watim Medical & Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410365
- Sponsor's protocol ID
- WM&DCR/R&D(ERB)/2023/64
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Semiz A, Akpak YK, Yilanlioglu NC, Babacan A, Gonen G, Cam Gonen C, Asiliskender M, Karakucuk S. Prediction of intraoperative nausea and vomiting in caesarean delivery under regional anaesthesia. J Int Med Res. 2017 Feb;45(1):332-339. doi: 10.1177/0300060516680547. Epub 2017 Jan 17.
PubMed 28222642Harris PH. General versus spinal anaesthesia. Br Med J (Clin Res Ed). 1985 Apr 27;290(6477):1286. doi: 10.1136/bmj.290.6477.1286-a. No abstract available.
PubMed 3921186Miao S, Shi M, Zou L, Wang G. Effect of intrathecal dexmedetomidine on preventing shivering in cesarean section after spinal anesthesia: a meta-analysis and trial sequential analysis. Drug Des Devel Ther. 2018 Nov 2;12:3775-3783. doi: 10.2147/DDDT.S178665. eCollection 2018.
PubMed 30464408Bi YH, Wu JM, Zhang YZ, Zhang RQ. Effect of Different Doses of Intrathecal Dexmedetomidine as an Adjuvant Combined With Hyperbaric Ropivacaine in Patients Undergoing Cesarean Section. Front Pharmacol. 2020 Mar 20;11:342. doi: 10.3389/fphar.2020.00342. eCollection 2020.
PubMed 32265713Rasooli S, Moslemi F, Khaki A. Effect of Sub hypnotic Doses of Propofol and Midazolam for Nausea and Vomiting During Spinal Anesthesia for Cesarean Section. Anesth Pain Med. 2014 Sep 16;4(4):e19384. doi: 10.5812/aapm.19384. eCollection 2014 Oct.
PubMed 25346896Gouveia F, Oliveira C, Losa N. Acupuncture in the Management of Intraoperative Nausea and Vomiting. J Acupunct Meridian Stud. 2016 Dec;9(6):325-329. doi: 10.1016/j.jams.2016.09.005. Epub 2016 Sep 17.
PubMed 28010836Dewinter G, Staelens W, Veef E, Teunkens A, Van de Velde M, Rex S. Simplified algorithm for the prevention of postoperative nausea and vomiting: a before-and-after study. Br J Anaesth. 2018 Jan;120(1):156-163. doi: 10.1016/j.bja.2017.08.003. Epub 2017 Nov 23.
PubMed 29397124Shoar S, Esmaeili S, Safari S. Pain management after surgery: a brief review. Anesth Pain Med. 2012 Winter;1(3):184-6. doi: 10.5812/kowsar.22287523.3443. Epub 2012 Jan 1.
PubMed 24904790
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intrathecal Versus Intravenous Dexmedetomidine Adjuvant to Bupivacaine in Elective Cesarian Section
- ClinicalTrials.gov ID
- NCT06410365
- Acronym / sponsor ID
- WM&DCR/R&D(ERB)/2023/64
- Conditions
- Nausea and Vomiting, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Muhammad IlyasUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 May 2024 (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 purpose of this research is to evaluate the impact of intrathecal dexmedetomidine in comparison with intravenous route in patients undergoing cesarean section.
Alternate hypothesis :Dexmedetomidine is more effective when given intrathecally as adjuvant to bupivacaine in elective cesarean section Null Hypothesis: Dexmedetomidine is more effective when given intravenously as adjuvant to bupivacaine in elective cesarean section Study Design: Randomized controlled trial Study setting: Watim General Hospital Study Duration: 18 months after synopsis approval Sampling technique: Simple random sampling Sample Size: Using the Open Epi program, a sample size of 60 patients (30 in each group) was determined with a 95% confidence interval and 80% power.
Inclusion Criteria:
- Pregnant women between ages 18-35 years
- Belongs to ASA class I or II
- Subjected to elective C-section
Exclusion Criteria:
- Any history of gastrointestinal disease diabetes, thyroid disease, hypertension, obesity, or anemia
- History of alcohol or drug abuse;
- Major complications of pregnancy
- Patients have contraindication to spinal block or allergic to any of drug
Detailed description
Introduction Cesarean section under spinal anesthesia has gained worldwide popularity in the past two, three decades as it provides quick, intense and balanced anesthesia. Patients may avoid the dangers of general anesthesia by having a cesarean section while still receiving anesthetic and pain relief via spinal anesthesia Patients still experience problems during surgical operations due to adverse effects produced by spinal anesthesia, such as nausea, vomiting and shivering, even though the risk is lower than that of general anesthetic One research estimates that as many as 55 percent of people shiver at some point throughout their lives .There may be adverse consequences on heart rate, oxygen saturation, and blood pressure from excessive shivering. Cardiopulmonary insufficiency increases the risk for potentially fatal side effects While there has been much research on nausea and vomiting after epidural anesthesia, less attention has been paid to IONV during the procedure itself Patients' comfort is diminished, hospital stays are prolonged, and more expenses are incurred when nausea and vomiting occur during surgery and remain thereafter. Considerable attention should be paid to this issue because of the seriousness of its potential outcomes, which include, among others, dehydration, electrolyte imbalance, wound dehiscence, venous hypertension and bleeding, esophageal rupture, airway obstruction, and aspiration pneumonia. In several types of surgeries, patients often have nausea and vomiting afterward However, caesarean sections performed with regional anesthesia have this issue more often . There are several factors that might put a patient at risk for IONV, including increased intragastric pressure, hypotension, extending the peritoneum (exteriorization of the uterus), extensive surgical manipulation and visceral stimulation, the use of opioids, the use of uterotonic drugs, and the patient's mental health. The hypotension that occurs during spinal, epidural, or spinal-epidural (combined) anesthesia is a major risk factor for ischemic optic neuropathy of the visual system. Procedure-specific factors that may lead to IONV include peritonealization, exteriorizing the uterus for suturing, and peritoneal cleaning IONV has an estimated 80 percent prevalence. As a result, preventative medicine is essential . Treatment rather than prevention has been the primary focus of previous IONV research. It seems that IONV may be improved by using a combination of preoperative and intraoperative midazolam and propofol, closely monitoring hypotension, attaining a good anesthetic block, doing surgery gently, and using uterotonic drugs sparingly.
Postoperative pain is still a major problem in healthcare all around the world, despite developments in anesthesiology and surgical methods. Poor pain management after surgery is linked to several unfavorable results, including patient dissatisfaction, low quality of life, slowed healing, and increasing reliance on drugs . Intrathecal block is the most popular method for anesthetizing patients undergoing C-sections, which is the most frequent surgical operation for women of childbearing age. Increased protection for both mother and child, a strong motor and sensory block, a low failure rate, and a reasonable price tag are just a few of the benefits it provides. Subarachnoid block, when done just with local anesthetics, has the fundamental drawback of providing only temporary relief from postoperative pain due to its limited duration of action. Adjuvants are often used to enhance the duration of analgesia by enhancing the quality of the block and lengthening the duration of analgesia . Intrathecally administering dexmedetomidine, a highly selective alpha-2 agonist, in combination with hyperbaric bupivacaine results in a much longer duration of analgesia and an improved safety profile .Studies on full-term patients having spinal anesthesia for elective caesarean sections indicated that the combination of Dexmedetomidine and bupivacaine was just as effective as morphine and bupivacaine for maintaining pain relief for a longer period of time showed that among ASA I or II patients undergoing caesarean delivery, the duration of analgesia produced by bupivacaine + Dexmedetomidine was significantly longer than the length provided by bupivacaine + placebo. Dexmedetomidine patients also had considerably decreased postoperative rescued sufentanil intake compared to those in the control group.
We expect that the addition of dexmedetomidine as an adjuvant to intrathecal hyperbaric bupivacaine would enhance intraoperative blockade conditions during cesarean section, extend postoperative sensory block, reduce nausea vomiting and shivering without affecting the motor block and with minimal additional adverse effects.
Data Collection:
Participant's demographic and clinical information will be obtained through a questionnaire and the patient will be randomly divided into two groups using lottery method. Participants in Group A will receive an intravenous dose of dexmedetomidine diluted in 20 milliliters of saline, with 1 milliliter withdrawn from a 2-milliliter syringe. Group B will receive intravenously one milliliter of 0.9% isotonic saline in a two milliliter syringe. The participant will be given a subarachnoid block in accordance with standard operating procedure. Group A will receive intrathecal 0.75% bupivacaine (1.2ml +1 ml N/S) and group B will receive intrathecal bupivacaine 0.75%(1.2ml+plus 5 μg Dex (diluted in N/S up to the volume of 1 ml intrathecally. T4-5 block will be achieved by turning the patient supine with left uterine displacement. . Intraoperative nausea and vomiting will be assessed using a a 4-point scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe) Postoperative pain will measured using a numeric pain rating scale (0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain) every 30 minutes in the postoperative care unit until the patient demanded their first analgesic dose, which will serve as the study's cut-off point. Injectable Ketorolac 30 mg will be used as a rescue analgesic
Data Analysis:
SPSS-23 will be used for the statistical analysis of the data. The duration of post-operative analgesia will be compared between the two groups using an independent sample t-test. Using stratification, we will be able to regulate potential confounding variables. To compare how long patients needed pain relief after surgery among groups, an independent samples t-test will be used after stratification. The cutoff for significance will be set at P≤0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrathecal dexmedetomidine+ bupivacaine | Experimental | Drug: Dexmedetomidine injectionintrathecal bupivacaine 0.75%(1.2ml+plus 5 μg Dex (diluted in N/S up to the volume of 1 ml intrathecally once |
| intravenous dexmedetomidine+ bupivacane | Experimental | Drug: Dexmedetomidine injectionintravenous dexmedetomidine 1mcg/kg in normal saline + intrathecal .75% bupivacaine (1.2ml) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women between ages 18-35 years
- Belongs to ASA class I or II
- Subjected to elective C-section
Key exclusion criteria (4 listed)
- Any history of gastrointestinal disease diabetes, thyroid disease, hypertension, obesity, or anaemia
- History of alcohol or drug abuse;
- Major complications of pregnancy
- Patients have contraindication to spinal block or allergic to any of drug
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 |
|---|---|---|
| Dexmedetomidine injectionAlso: BupivacaineComparison of intravenous and intrathecal route of dexmedetomidine | Drug | intrathecal dexmedetomidine+ bupivacaine, intravenous dexmedetomidine+ bupivacane |
Primary outcome
To evaluate the impact of clinical efficacy of intrathecal versus intravenous dexmedetomidine on intraoperative nausea vomiting,shivering and postoperative pain
Time frame: during cesarean section surgery
Intraoperative nausea and vomiting will be assessed using a a 4-point scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe) Postoperative pain will measured using a numeric pain rating scale (0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain) every 30 minutes in the postoperative care
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 28222642Semiz A, Akpak YK, Yilanlioglu NC, Babacan A, Gonen G, Cam Gonen C, Asiliskender M, Karakucuk S. Prediction of intraoperative nausea and vomiting in caesarean delivery under regional anaesthesia. J Int Med Res. 2017 Feb;45(1):332-339. doi: 10.1177/0300060516680547. Epub 2017 Jan 17.
- Background: PubMed 3921186Harris PH. General versus spinal anaesthesia. Br Med J (Clin Res Ed). 1985 Apr 27;290(6477):1286. doi: 10.1136/bmj.290.6477.1286-a. No abstract available.
- Background: PubMed 30464408Miao S, Shi M, Zou L, Wang G. Effect of intrathecal dexmedetomidine on preventing shivering in cesarean section after spinal anesthesia: a meta-analysis and trial sequential analysis. Drug Des Devel Ther. 2018 Nov 2;12:3775-3783. doi: 10.2147/DDDT.S178665. eCollection 2018.
- Background: PubMed 32265713Bi YH, Wu JM, Zhang YZ, Zhang RQ. Effect of Different Doses of Intrathecal Dexmedetomidine as an Adjuvant Combined With Hyperbaric Ropivacaine in Patients Undergoing Cesarean Section. Front Pharmacol. 2020 Mar 20;11:342. doi: 10.3389/fphar.2020.00342. eCollection 2020.
- Background: PubMed 25346896Rasooli S, Moslemi F, Khaki A. Effect of Sub hypnotic Doses of Propofol and Midazolam for Nausea and Vomiting During Spinal Anesthesia for Cesarean Section. Anesth Pain Med. 2014 Sep 16;4(4):e19384. doi: 10.5812/aapm.19384. eCollection 2014 Oct.
- Background: PubMed 28010836Gouveia F, Oliveira C, Losa N. Acupuncture in the Management of Intraoperative Nausea and Vomiting. J Acupunct Meridian Stud. 2016 Dec;9(6):325-329. doi: 10.1016/j.jams.2016.09.005. Epub 2016 Sep 17.
- Background: PubMed 29397124Dewinter G, Staelens W, Veef E, Teunkens A, Van de Velde M, Rex S. Simplified algorithm for the prevention of postoperative nausea and vomiting: a before-and-after study. Br J Anaesth. 2018 Jan;120(1):156-163. doi: 10.1016/j.bja.2017.08.003. Epub 2017 Nov 23.
- Background: PubMed 24904790Shoar S, Esmaeili S, Safari S. Pain management after surgery: a brief review. Anesth Pain Med. 2012 Winter;1(3):184-6. doi: 10.5812/kowsar.22287523.3443. Epub 2012 Jan 1.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine injection in people with Nausea and Vomiting, Postoperative, run by Muhammad Ilyas.
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 4 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: status not confirmed, as of the sponsor's last update on 13 May 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sadia Lodhi, MBBS,MPhil (00923345101061, drsadiajunaid07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the impact of clinical efficacy of intrathecal versus intravenous dexmedetomidine on intraoperative nausea vomiting,shivering and postoperative pain (time frame: during cesarean section surgery). 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 NCT06410365, which also lists 8 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 13 May 2024.