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

Primary Purpose

Morphine Adverse Reaction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Atropine and Dexamethasone
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morphine Adverse Reaction

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    Dexamethasone group (D)

    Atropine group (A)

    Dexamethasone and Atropine group (DA)

    Arm 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hyperbaric bupivacaine 0.5% in a dose of 12.5 mg (2.5 ml) mixed with morphine in a dose of 200 µg (0.5 ml was withdrawn from a syringe containing 4 mg morphine sulfate diluted in 10 ml normal saline) [Total volume 4 ml], followed by intrathecal dexamethasone 4 mg (1ml).

    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hyperbaric bupivacaine 12.5 mg (2.5 ml 0.5%) mixed with morphine 200 µg (0.5 ml) and atropine100 µg (0.5 ml was withdrawn from a syringe containing 2 mg atropine sulfate diluted in 10 ml normal saline) [Total volume 3.5 ml].

    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] .

    Outcomes

    Primary Outcome Measures

    Incidence and severity of PONV
    Incidence and severity of PONV by designing questionnaire and specific scale: no nausea or vomiting mild nausea and vomiting but no need to treatment moderate nausea and vomiting that need treatment severe form of nausea and vomiting and resistant to treatment

    Secondary Outcome Measures

    Antiemetic
    Total dose of post-operative rescue antiemetic (ondansetron in mg) for 24 hour
    Post-operative pain profile
    Post-operative visual analog scale (1: no pain and 10: the most severe experienced pain ) for 24 hour.
    Incidence of Side Effects
    Anticipated side effects as shivering and hypotension( number of patients and severity)
    Analgesia
    Time to the first post-operative rescue analgesic for 24 hour.

    Full Information

    First Posted
    September 17, 2022
    Last Updated
    September 30, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05560542
    Brief Title
    Intrathecal Dexamethasone and Atropine on Morphine Induced Post-operative Nausea and Vomiting on Caesarean Section
    Official Title
    Prophylactic Efficacy and Safety of Intrathecal Dexamethasone, Atropine or Their Combination on Morphine Induced Post-operative Nausea and Vomiting on Patients Undergoing Caesarean Section With Spinal Anaesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    March 1, 2025 (Anticipated)
    Study Completion Date
    October 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morphine Adverse Reaction

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexamethasone group (D)
    Arm Type
    Other
    Arm 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).
    Arm Title
    Atropine group (A)
    Arm Type
    Other
    Arm 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].
    Arm Title
    Dexamethasone and Atropine group (DA)
    Arm Type
    Other
    Arm 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] .
    Intervention Type
    Drug
    Intervention Name(s)
    Atropine and Dexamethasone
    Intervention Description
    Intrathecal dexamethasone, atropine or their combination.
    Primary Outcome Measure Information:
    Title
    Incidence and severity of PONV
    Description
    Incidence and severity of PONV by designing questionnaire and specific scale: no nausea or vomiting mild nausea and vomiting but no need to treatment moderate nausea and vomiting that need treatment severe form of nausea and vomiting and resistant to treatment
    Time Frame
    24 hour
    Secondary Outcome Measure Information:
    Title
    Antiemetic
    Description
    Total dose of post-operative rescue antiemetic (ondansetron in mg) for 24 hour
    Time Frame
    24 hour
    Title
    Post-operative pain profile
    Description
    Post-operative visual analog scale (1: no pain and 10: the most severe experienced pain ) for 24 hour.
    Time Frame
    24 hour
    Title
    Incidence of Side Effects
    Description
    Anticipated side effects as shivering and hypotension( number of patients and severity)
    Time Frame
    24 hour
    Title
    Analgesia
    Description
    Time to the first post-operative rescue analgesic for 24 hour.
    Time Frame
    24 hour

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Adult Pregnant Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female 18-45 years old ASA: 1, 2 Elective caesarean section under spinal anaesthesia. Exclusion Criteria: Patient refusal. Contraindications to spinal anaesthesia as coagulopathy, infection at site of injection, hemodynamic instability and uncooperative patient. Contraindications to administration of morphine as asthmatic patient and hypersensitivity and contraindications to any of the study drugs. Adult-Emergency CS as there is no time for preparation and risk on fetus and mother for time consuming

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    29268061
    Citation
    Araujo R; PAMA Trial. [Pain Management, Local Infection, Satisfaction, Adverse Effects and Residual Pain after Major Open Abdominal Surgery: Epidural versus Continuous Wound Infusion (PAMA Trial)]. Acta Med Port. 2017 Oct 31;30(10):683-690. doi: 10.20344/amp.8600. Epub 2017 Oct 31. Portuguese.
    Results Reference
    background
    PubMed Identifier
    10072014
    Citation
    Gwirtz KH, Young JV, Byers RS, Alley C, Levin K, Walker SG, Stoelting RK. The safety and efficacy of intrathecal opioid analgesia for acute postoperative pain: seven years' experience with 5969 surgical patients at Indiana University Hospital. Anesth Analg. 1999 Mar;88(3):599-604. doi: 10.1097/00000539-199903000-00026.
    Results Reference
    background
    PubMed Identifier
    24106351
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21079721
    Citation
    Rusch D, Eberhart LH, Wallenborn J, Kranke P. Nausea and vomiting after surgery under general anesthesia: an evidence-based review concerning risk assessment, prevention, and treatment. Dtsch Arztebl Int. 2010 Oct;107(42):733-41. doi: 10.3238/arztebl.2010.0733. Epub 2010 Oct 22.
    Results Reference
    background
    PubMed Identifier
    10598635
    Citation
    Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.
    Results Reference
    background
    PubMed Identifier
    24356162
    Citation
    Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. Erratum In: Anesth Analg. 2014 Mar;118(3):689. Anesth Analg. 2015 Feb;120(2):494.
    Results Reference
    background
    PubMed Identifier
    10389804
    Citation
    Wang JJ, Ho ST, Lee SC, Liu YC, Liu YH, Liao YC. The prophylactic effect of dexamethasone on postoperative nausea and vomiting in women undergoing thyroidectomy: a comparison of droperidol with saline. Anesth Analg. 1999 Jul;89(1):200-3. doi: 10.1097/00000539-199907000-00036.
    Results Reference
    background

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

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