Nausea and Vomiting, Postoperative Clinical Trial
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. 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
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | 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 anaemia - History of alcohol or drug abuse; - Major complications of pregnancy - Patients have contraindication to spinal block or allergic to any of drug |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Muhammad Ilyas |
Bi 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. — View Citation
Dewinter 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. — View Citation
Gouveia 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. — View Citation
Harris 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. — View Citation
Miao 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. — View Citation
Rasooli 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. — View Citation
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. — View Citation
Shoar 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | during cesarean section surgery |
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