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Intrathecal Dexamethasone and Atropine on Morphine Induced Post-operative Nausea and Vomiting on Caesarean Section

A

Assiut University

Status

Not yet enrolling

Conditions

Morphine Adverse Reaction

Treatments

Drug: Atropine and Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT05560542
AAD-PONV-SCS

Details and patient eligibility

About

Pain is a major problem during the postoperative period and can be considered as a challenge for the anesthesiologist. Low dose intrathecal morphine is proven efficient as a mode to reduce postoperative pain. Morphine has many complications like post-operative nausea and vomiting (PONV). the investigators will investigate the utility of intrathecal (IT) atropine and dexamethasone for prevention of morphine induced PONV as a primary outcome in parturient undergoing CS under spinal bupivacaine anesthesia plus morphine sulfate as an adjuvant.

Full description

Pain is a major problem during the postoperative period and can be considered as a challenge for the anesthesiologist. Low dose intrathecal morphine is proven efficient as a mode to reduce postoperative pain in many surgical areas including Caesarean delivery. Morphine has many complications namely pruritus, and post-operative nausea and vomiting (PONV). The other risk factors for the development of PONV include female gender, non-smoker status, general anesthesia with inhalational anesthetics and surgical factors (duration and type of surgery). The supplementation of morphine, however raises the occurrences of postoperative nausea and vomiting (PONV) in these patient To tackle this problem, the investigators have to use the combination therapy of antiemetics like a serotonin receptor antagonist of either intravenous (IV) ondansetron or granisetron with IV dexamethasone is administered after the administration of intrathecal morphine. Dopamine receptor antagonists e.g. droperidol and metoclopramide are commonly used, but they carry the risk of extrapyramidal symptoms.

Enrollment

150 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Female
  2. 18-45 years old
  3. ASA: 1, 2
  4. Elective caesarean section under spinal anaesthesia.

Exclusion criteria

  1. Patient refusal.
  2. Contraindications to spinal anaesthesia as coagulopathy, infection at site of injection, hemodynamic instability and uncooperative patient.
  3. Contraindications to administration of morphine as asthmatic patient and hypersensitivity and contraindications to any of the study drugs.
  4. Adult-Emergency CS as there is no time for preparation and risk on fetus and mother for time consuming

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 3 patient groups

Dexamethasone group (D)
Other group
Description:
Patients will receive intrathecal hyperbaric bupivacaine 0.5% in a dose of 12.5 mg (2.5 ml) mixed with morphine in a dose of 200 µg (0.5 ml was withdrawn from a syringe containing 4 mg morphine sulfate diluted in 10 ml normal saline) \[Total volume 4 ml\], followed by intrathecal dexamethasone 4 mg (1ml).
Treatment:
Drug: Atropine and Dexamethasone
Atropine group (A)
Other group
Description:
Patients will receive intrathecal hyperbaric bupivacaine 12.5 mg (2.5 ml 0.5%) mixed with morphine 200 µg (0.5 ml) and atropine100 µg (0.5 ml was withdrawn from a syringe containing 2 mg atropine sulfate diluted in 10 ml normal saline) \[Total volume 3.5 ml\].
Treatment:
Drug: Atropine and Dexamethasone
Dexamethasone and Atropine group (DA)
Other group
Description:
Patients will receive intrathecal hyperbaric bupivacaine in a dose of 12.5 mg (2.5 ml) mixed with morphine 200 µg (0.5 ml) and atropine 100 µg (0.5 ml), followed by intrathecal injection of dexamethasone 4 mg (1 ml) \[Total volume 4.5 ml\] .
Treatment:
Drug: Atropine and Dexamethasone

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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