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

NCT05560542 | Completed

• 1 other identifier: AAD-PONV-SCS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Morphine Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of PONV

  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

  24 hour

Secondary Outcomes (4)

• Antiemetic

  24 hour

• Post-operative pain profile

  24 hour

• Incidence of Side Effects

  24 hour

• Analgesia

  24 hour

Study Arms (3)

Dexamethasone group (D)

OTHER

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hyperbaric bupivacaine 0.5% in a dose of 12.5 mg (2.5 ml) mixed with morphine in a dose of 200 µg (0.5 ml was withdrawn from a syringe containing 4 mg morphine sulfate diluted in 10 ml normal saline) \[Total volume 4 ml\], followed by intrathecal dexamethasone 4 mg (1ml).

Drug: Atropine and Dexamethasone

Atropine group (A)

OTHER

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hyperbaric bupivacaine 12.5 mg (2.5 ml 0.5%) mixed with morphine 200 µg (0.5 ml) and atropine100 µg (0.5 ml was withdrawn from a syringe containing 2 mg atropine sulfate diluted in 10 ml normal saline) \[Total volume 3.5 ml\].

Drug: Atropine and Dexamethasone

Dexamethasone and Atropine group (DA)

OTHER

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) \[Total volume 4.5 ml\] .

Drug: Atropine and Dexamethasone

Interventions

Atropine and Dexamethasone DRUG

Intrathecal dexamethasone, atropine or their combination.

Atropine group (A); Dexamethasone and Atropine group (DA); Dexamethasone group (D)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Adult Pregnant Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• years old
• ASA: 1, 2
• Elective caesarean section under spinal anaesthesia.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university, faculty of medicine

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (7)

• 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.

  PMID: 29268061 BACKGROUND

• 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.

  PMID: 10072014 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 21079721 BACKGROUND

• 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.

  PMID: 10598635 BACKGROUND

• 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.

  PMID: 24356162 BACKGROUND

• 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.

  PMID: 10389804 BACKGROUND

MeSH Terms

Interventions

Atropine; Dexamethasone

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesia and ICU Resident

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: September 29, 2022
• Study Start: October 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

EG (1)