Morphine Adverse Reaction
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGAtropine and Dexamethasone
Intrathecal dexamethasone, atropine or their combination.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of PONV | 24 hour | Incidence and severity of PONV by designing questionnaire and specific scale: 1. no nausea or vomiting 2. mild nausea and vomiting but no need to treatment 3. moderate nausea and vomiting that need treatment 4. severe form of nausea and vomiting and resistant to treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antiemetic | 24 hour | Total dose of post-operative rescue antiemetic (ondansetron in mg) for 24 hour |
| Post-operative pain profile | 24 hour | Post-operative visual analog scale (1: no pain and 10: the most severe experienced pain ) for 24 hour. |
| Incidence of Side Effects | 24 hour | Anticipated side effects as shivering and hypotension( number of patients and severity) |
| Analgesia | 24 hour | Time to the first post-operative rescue analgesic for 24 hour. |
Countries
Egypt
Outcome results
None listed