Effect of Propofol Administration Time on the Incidence and Severity of Intrathecal Morphine-induced Pruritus in Parturient Undergoing Elective Cesarean Delivaries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Morphine intrathecal, propofol, propofol.
- Who it may be relevant to
- Registry conditions: Cesarean Section. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Propofol Administration Time on the Incidence and Severity of Intrathecal Morphine-induced Pruritus in Parturient Undergoing Elective Cesarean Delivaries: A Prospective, Randomized, Comparative Controlled Study
Overview
Our hypothesis suggests that Administration time of intravenous propofol may affect Pruritus incidence and severity that occur after intrathecal morphine in parturient undergoing elective cesarean section (CS). the aim of the study is to investigate effect of prophylactic administration of intravenous sub-hypnotic dose of propofol before intrathecal morphine compared with the administration after intrathecal morphine on intrathecal morphine-induced pruritus incidence and severity in parturient undergoing elective cesarean delivaries.
Detailed description
Neuraxial Anaesthesia is a frequent anaesthetic approach for cesarean delivery and other lower abdominal and lower limb anaesthetic procedures. Neuraxial morphine addition to local anaesthetic provides an effective and prolonged postoperative analgesia, but has been associated with a frequent incidence of pruritus and postoperative nausea and vomiting (PONV).
Neuraxial opioids are thought to act on central nervous system pathways to cause pruritus. Although precise mechanisms are incompletely understood, Numerous interventions have been investigated to prevent opioid-induced pruritus in the peripartum period as: Opioid receptor agonist-antagonists, Serotonin receptor antagonists.
There is dense concentration of opioid receptors and 5-HT3 receptors in the dorsal part of the spinal cord and nucleus of the spinal tract of the trigeminal nerve in the medulla. Activation of these receptors by neuraxial opioid administration or by circulating estrogen in parturient results in pruritus which is usually localized to face, neck, or upper thorax.
Propofol exerts its antipruritic action through inhibition of the posterior horn transmission in spinal cord. Series of clinical trials have reported that a sub-hypnotic dose of propofol is equally effective in reducing the incidence of pruritus following intrathecal morphine. however these studies have limited information about dose and timing of administration of propofol.
Interventions
- Drug Morphine intrathecal
patients intrathecal anaesthesia with morphine - Drug propofol
patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection 15 min before the end of surgery - Drug propofol
patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection just before intrathecal anaesthesia
Primary outcome measures
- severity of pruritus that occurs after intrathecal morphine in parturient undergoing elective cesarean section (CS) by pruritus Grading system. [Time frame: 24 hours]
Eligibility criteria
Inclusion criteria
- Parturient of American Society of Anaesthesiologists (ASA) class I or II physical status.
- Age: 20-40 years.
- At term gestation (≥ 37 weeks) with a singleton uncomplicated pregnancy.
- Elective cesarean delivery under intrathecal anaesthesia
Exclusion criteria
- Parturient refusal.
- Significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).
- Morbid obesity (BMI >35).
- Parturient with known hypersensitivity to propofol, morphine or amide local anaesthetics.
- Parturient with pruritogenic systemic disease.
- A coexisting skin disorder or preexisting pregnancy induced pruritus.
- Parturient with any contraindication for intrathecal anaesthesia, e.g. coagulopathy.
- Emergency cesarean section.
- Failed or unsatisfactory intrathecal block.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Kumar K, Singh SI. Neuraxial opioid-induced pruritus: An update. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):303-7. doi: 10.4103/0970-9185.117045. PMID 24106351
- Singh PM, Sultan P, O'Carroll J, Blake L, Carvalho B, Singh NP, Monks DT. Pharmacological agents for prevention of pruritus in women undergoing Caesarean delivery with neuraxial morphine: a systematic review and Bayesian network meta-analysis. Br J Anaesth. 2023 Sep;131(3):556-571. doi: 10.1016/j.bja.2023.05.028. Epub 2023 Jul 14. PMID 37455197
- Kampo S, Afful AP, Mohammed S, Ntim M, Buunaaim ADB, Anabah TW. Sub-hypnotic dose of propofol as antiemetic prophylaxis attenuates intrathecal morphine-induced postoperative nausea and vomiting, and pruritus in parturient undergoing cesarean section - a randomized control trial. BMC Anesthesiol. 2019 Sep 14;19(1):177. doi: 10.1186/s12871-019-0847-y. PMID 31521119
Identifiers
NCT: NCT06715657 · propofol pruritus incidence CS