PONV Clinical Trial
Official title:
Granisetron vs Granisetron and Dexamethasone on the Reduction of Postoperative Nausea and Vomiting After Caesarean Section With Intrathecal Morphine: A Randomized Controlled Trial
Verified date | September 2020 |
Source | Universiti Sains Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Intrathecal morphine (ITM) has proven to be excellent in reducing postoperative pain. However, its use has commonly been associated with the occurrence of postoperative nausea and vomiting (PONV). In recent years, the combination therapy of antiemetics comprising of a serotonin receptor antagonist and corticosteroid has been implemented to diminish the occurrence of PONV. Despite being routinely used, the evidence in the efficacy of this combination in parturients are conflicting and lacking. In this study, we wish to compare the efficacy between the combination therapy of granisetron plus dexamethasone versus granisetron alone on the occurrence of postoperative nausea and vomiting (PONV) in 126 parturients undergoing elective Caesarean delivery supplemented with intrathecal morphine.
Status | Recruiting |
Enrollment | 126 |
Est. completion date | June 1, 2021 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - American Society of Anaesthesiologists (ASA) I-II category - 2 risks factors or more for PONV according to Apfel Score. Exclusion Criteria: - Unfit for spinal anaesthesia. - Coagulopathy - Uncorrected hypovolemia - Indeterminate neurologic disease - Infection at site of injection - Raised intracranial pressure(ICP) - Morbidly obese patients, BMI> 40 kg/m2 according to ICD-10 (International Statistical Classification of Diseases 10) - Patients allergic towards morphine. - Contraindicated for antiemetics use - Granisetron: allergy towards Granisetron, prolonged QT interval - Ondansetron: allergy towards ondansetron, prolonged QT interval - Dexamethasone: allergy towards Dexamethasone, uncontrolled Diabetes Mellitus (DM). |
Country | Name | City | State |
---|---|---|---|
Malaysia | Universiti Sains Malaysia, Health Campus | Kubang Kerian | Kelantan |
Lead Sponsor | Collaborator |
---|---|
Universiti Sains Malaysia |
Malaysia,
Abouleish E, Rawal N, Fallon K, Hernandez D. Combined intrathecal morphine and bupivacaine for cesarean section. Anesth Analg. 1988 Apr;67(4):370-4. — View Citation
Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. — View Citation
Dahl JB, Jeppesen IS, Jørgensen H, Wetterslev J, Møiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. Review. — View Citation
Gwirtz KH, Young JV, Byers RS, Alley C, Levin K, Walker SG, Stoelting RK. The safety and efficacy of intrathecal opioid analgesia for acute postoperative pain: seven years' experience with 5969 surgical patients at Indiana University Hospital. Anesth Analg. 1999 Mar;88(3):599-604. — View Citation
Sfeir S, Mansour N. Post operative analgesia with intrathecal morphine. Middle East J Anaesthesiol. 2005 Feb;18(1):133-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparing the incidence of post operative nausea and vomiting (PONV) | To compare the incidence of nausea, retching and vomiting at 1 hour, 4 hourly for 12 hours and at 24 hours postoperatively between parturients receiving combination therapy of Granisetron plus Dexamethasone versus that of Granisetron alone | From 1 to 24 hour post operatively | |
Secondary | Comparing the requirement of rescue antiemetic between both groups | To compare the requirement of rescue antiemetic between 1 hour, 4 hourly for 12 hours and at 24 hours postoperatively between parturients receiving combination therapy of Granisetron plus Dexamethasone versus that of Granisetron alone | From 1 to 24 hour post operatively |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01945502 -
Nasopharyngeal Packing and Rhinologic Surgery.
|
N/A | |
Completed |
NCT01840254 -
Effect of Combination Dexmedetomidine Added to Fentanyl-based Intravenous Patient-controlled Analgesia on Nausea Vomiting in Highly Susceptible Patients Undergoing Lumbar Spinal Surgery: Prospective Double Blinded Randomized Controlled Trial
|
N/A | |
Completed |
NCT00760253 -
Compare the Side Effects and Difference Awake Level of Three TCI Propofol Formula in TVOR Patients
|
N/A | |
Completed |
NCT00772226 -
The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit
|
Phase 3 | |
Recruiting |
NCT03783182 -
Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy
|
Phase 4 | |
Recruiting |
NCT03835234 -
Incidence and Factors Associated With PONV in Regional Anaesthesia
|
||
Recruiting |
NCT04191694 -
Chewing Gum to Prevent Nausea and Vomiting After Caesarean Section Under Spinal Anaesthesia
|
N/A | |
Completed |
NCT02468323 -
Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia
|
Phase 4 | |
Recruiting |
NCT05596695 -
Minimisation of Blood Pressure Variability and Postoperative Nausea and Vomiting
|
N/A | |
Completed |
NCT02116257 -
The Opioid-sparing Effect and Reduced PONV Using Propacetamol in PCA Among Patients With High Risk of PONV
|
N/A | |
Not yet recruiting |
NCT05396716 -
Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting
|
N/A | |
Active, not recruiting |
NCT00892996 -
Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section
|
N/A | |
Recruiting |
NCT04866121 -
Acupuncture for Prevention of Postoperative Nausea and Vomiting
|
N/A | |
Completed |
NCT02809378 -
The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of PONV
|
Phase 4 | |
Completed |
NCT05408676 -
Comparison of Dexamethasone Alone vs in Combination With Pericardium 6 (P6) Electrical Stimulation or Granisetron in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Breast Cancer Surgery
|
N/A | |
Completed |
NCT01991821 -
European Phase III Study of APD421 in PONV
|
Phase 3 | |
Completed |
NCT00952133 -
Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV
|
Phase 4 | |
Completed |
NCT04054479 -
Penehyclidine for PONV Prophylaxis After Strabismus Surgery
|
Phase 4 | |
Completed |
NCT05540236 -
Effects of Auricular Acupressure on the Management of Postoperative Nausea and Vomiting After Gynecological Laparoscopic Surgeries
|
N/A | |
Completed |
NCT03278522 -
Ramosetron Pre-treatment for PONV and QT Prolongation
|
Phase 4 |