IV and Intrathecal Ketamine in Cesarean Section

NCT ID: NCT05679375

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-10-31

Brief Summary

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In the current study, the investigators will compare the effects of low-dose intravenous (i.v.) ketamine versus intrathecal Ketamine added to spinal anesthesia on the time to first request for analgesia and maternal pain scores and overall satisfaction in patients undergoing cesarean section.

Detailed Description

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Conditions

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Cesarean Section Analgesia

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Intrathecal Ketamine

Patients will receive intrathecal Ketamine 0.1mg/kg added to bupivacaine and morphine.

Group Type ACTIVE_COMPARATOR

Intrathecal ketamine

Intervention Type DRUG

Patients will receive intrathecal Ketamine 0.1mg/kg added to bupivacaine and morphine

Intravenous ketamine

Patients will receive IV Ketamine 0.25mg/kg after spinal anesthesia with bupivacaine and morphine.

Group Type ACTIVE_COMPARATOR

Intravenous ketamine

Intervention Type DRUG

Patients will receive IV Ketamine 0.25mg/kg after spinal

Interventions

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Intrathecal ketamine

Patients will receive intrathecal Ketamine 0.1mg/kg added to bupivacaine and morphine

Intervention Type DRUG

Intravenous ketamine

Patients will receive IV Ketamine 0.25mg/kg after spinal

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

• Pregnant undergoing elective cesarean section

Exclusion Criteria

* Significant coexisting diseases (pregnancy-induced hypertension or diabetes)
* body mass index ≥40kg/m2, height \<150cm
* Current use of pain medication including opioids
* history of substance abuse or hallucinations, cardiovascular disease, diabetes, multiple gestations
* chronic pain was excluded.
* contraindications to spinal anaesthesia,
* severely compromised fetus requiring general anesthesia and those patients who received labor analgesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Youstina Tharwat Sedky

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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Abd El-Rahman AM, Mohamed AA, Mohamed SA, Mostafa MAM. Effect of Intrathecally Administered Ketamine, Morphine, and Their Combination Added to Bupivacaine in Patients Undergoing Major Abdominal Cancer Surgery a Randomized, Double-Blind Study. Pain Med. 2018 Mar 1;19(3):561-568. doi: 10.1093/pm/pnx105.

Reference Type BACKGROUND
PMID: 28520955 (View on PubMed)

Other Identifiers

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Ketamine in Cesarean section

Identifier Type: -

Identifier Source: org_study_id

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