Effect of Propofol Administration Time on the Incidence and Severity of Intrathecal Morphine-induced Pruritus in Parturient Undergoing Elective Cesarean Delivaries

NCT ID: NCT06715657

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-01-01

Brief Summary

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.

Conditions

Cesarean Section

Keywords

propofol administration time; intrathecal morphine-induced pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

Patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection 15 min before the end of surgery

Group Type: EXPERIMENTAL

Morphine intrathecal

Intervention Type: DRUG

patients intrathecal anaesthesia with morphine

propofol

Intervention Type: DRUG

patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection 15 min before the end of surgery

Group B

Patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection just before intrathecal anaesthesia

Group Type: EXPERIMENTAL

Morphine intrathecal

Intervention Type: DRUG

patients intrathecal anaesthesia with morphine

propofol

Intervention Type: DRUG

patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection just before intrathecal anaesthesia

Group C

patients will receive intrathecal anaesthesia with morphine without other intervention

Group Type: PLACEBO_COMPARATOR

Morphine intrathecal

Intervention Type: DRUG

patients intrathecal anaesthesia with morphine

Interventions

Morphine intrathecal

patients intrathecal anaesthesia with morphine

Intervention Type: 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

Intervention Type: DRUG

propofol

patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection just before intrathecal anaesthesia

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Esraa Essam Elsayed Mohamed

resident doctor at Anaesthesia ,Intensive care & pain management Faculty of Medicine, Assiut University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Esraa Essam Elsayed Mohamed, resident doctor

Role: CONTACT

Phone: +201004879065

Email: Esraa.16282364@med.aun.edu.eg

References

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.

Reference Type: RESULT

PMID: 24106351 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37455197 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31521119 (View on PubMed)

Other Identifiers

propofol pruritus incidence CS

Identifier Type: -

Identifier Source: org_study_id