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

NCT06715657 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: propofol pruritus incidence CS
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cesarean Section

Keywords

propofol administration time; intrathecal morphine-induced pruritus

Outcome Measures

Primary Outcomes (1)

• severity of pruritus that occurs after intrathecal morphine in parturient undergoing elective cesarean section (CS) by pruritus Grading system.

  the pruritus grading score (PGS) score (Firas et al, 2012) for each patient which is based on: distribution, frequency, severity of itch, and quality of sleep Each patient's itch grade is calculated as the sum of the individual scores: Mild grade: if the total score is between 0 and 5. Moderate grade: if the total score is between 6 and 11. Severe grade: if the total score is between 12 and 19.

  24 hours

Study Arms (3)

Group A

EXPERIMENTAL

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: Morphine intrathecal; Drug: propofol

Group B

EXPERIMENTAL

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

Drug: Morphine intrathecal; Drug: propofol

Group C

PLACEBO COMPARATOR

patients will receive intrathecal anaesthesia with morphine without other intervention

Drug: Morphine intrathecal

Interventions

Morphine intrathecal DRUG

patients intrathecal anaesthesia with morphine

Group A; Group B; Group C

propofol 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 A

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Esraa Essam Elsayed Mohamed, resident doctor

CONTACT

+201004879065; Esraa.16282364@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Anaesthesia ,Intensive care & pain management Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-11