Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia for Caesarean Section

NCT00921102 | Completed Phase 4

• 1 other identifier: ANEST-OST-01
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to assess the efficacy of atropine in preventing nausea and vomiting after spinal anesthesia with local anesthetic and morphine for elective Caesarean section. Patients enrolling in the study will be assigned to one of three groups. One will receive a small dose of intrathecal atropine; another will receive small-dose intravenous atropine; the third group will receive placebo.

Conditions

Cesarean Section; Anesthesia,Spinal; Postoperative Nausea and Vomiting

Keywords

Atropine; Morphine; Analgesics, Opioid; Antiemetics

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nausea and vomiting (PONV) as expressed by at least one rating > 3 on a numerical rating scale (0-10).

  12 hours post-operatively

Secondary Outcomes (3)

• Incidence and prevalence of PONV up to 24 h postoperatively, expressed as both ratings on a numerical rating scale and as the area under the curve of these ratings over time.

  Up to 24 h postoperatively

• Incidence of atropine-related side effects such as xerostomia, anxiety, tachycardia.

  Up to 24 h postoperatively

• Postoperative pain expressed as time to first request for supplemental analgesia and as rating on a numerical rating scale.

  Up to 24 h postoperatively

Study Arms (3)

Control

PLACEBO COMPARATOR

Patients in this group will receive both an intrathecal and intravenous injection of saline solution, as a placebo comparator.

Drug: Bupivacaine; Drug: Morphine; Drug: Isotonic saline solution

Intrathecal Atropine

EXPERIMENTAL

Patients in this group will receive intrathecal atropine as a prophylactic antiemetic agent. They will also receive intravenous saline solution to maintain blinding.

Drug: Bupivacaine; Drug: Morphine; Drug: Isotonic saline solution; Drug: Atropine

IV Atropine

ACTIVE COMPARATOR

Patients in this group will receive a small dose of atropine via the intravenous route to examine its possible antiemetic activity. They will also receive intravenous saline solution to maintain blinding.

Drug: Bupivacaine; Drug: Morphine; Drug: Isotonic saline solution; Drug: Atropine

Interventions

Bupivacaine DRUG

12.5 mg of a 5 mg/ml hyperbaric solution, intrathecally

Also known as: Local Anesthetic, Hyperbaric Bupivacaine, Marcain Heavy Injection

Control; IV Atropine; Intrathecal Atropine

Morphine DRUG

200 µg of a 200 µg/ml solution, intrathecally

Control; IV Atropine; Intrathecal Atropine

Isotonic saline solution DRUG

0.9% NaCl solution 0.1 ml, intrathecally in group Control and IV Atropine 0.1 ml, intravenously in group Control and Intrathecal Atropine

Also known as: Sodium chloride

Control; IV Atropine; Intrathecal Atropine

Atropine DRUG

100 µg of a 1 mg/ml preservative-free solution * intrathecally in group Intrathecal Atropine * intravenously in group IV Atropine

IV Atropine; Intrathecal Atropine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective Cesarean section at up to 42 weeks and 2 days
• Patients in ASA Physical Status Class I or II
• Informed written consent to participation
• No known gestosis

You may not qualify if:

• Any known fetal pathology
• Indication to general anesthesia
• Known allergy to any of the study drugs
• Baseline bradycardia or any cardiovascular disease

Sponsors & Collaborators

• University of Parma: lead

Study Sites (2)

University of Messina

Messina, ME, 98122, Italy

Location

University and Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma)

Parma, PR, 43126, Italy

Location

Related Publications (5)

• Ramaioli F, De Amici D. Central antiemetic effect of atropine: our personal experience. Can J Anaesth. 1996 Oct;43(10):1079. doi: 10.1007/BF03011915. No abstract available.

  PMID: 8896865 BACKGROUND

• Salmenpera M, Kuoppamaki R, Salmenpera A. Do anticholinergic agents affect the occurrence of postanaesthetic nausea? Acta Anaesthesiol Scand. 1992 Jul;36(5):445-8. doi: 10.1111/j.1399-6576.1992.tb03494.x.

  PMID: 1632167 BACKGROUND

• Moscovici R, Prego G, Schwartz M, Steinfeld O. Epidural scopolamine administration in preventing nausea after epidural morphine. J Clin Anesth. 1995 Sep;7(6):474-6. doi: 10.1016/0952-8180(95)00056-n.

  PMID: 8534463 BACKGROUND

• Kotelko DM, Rottman RL, Wright WC, Stone JJ, Yamashiro AY, Rosenblatt RM. Transdermal scopolamine decreases nausea and vomiting following cesarean section in patients receiving epidural morphine. Anesthesiology. 1989 Nov;71(5):675-8. doi: 10.1097/00000542-198911000-00009.

  PMID: 2817461 BACKGROUND

• Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.

  PMID: 34002866 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Bupivacaine; Anesthetics, Local; Morphine; Sodium Chloride; Atropine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Bridged Bicyclo Compounds, Heterocyclic

Study Officials

• Guido Fanelli, MD

  University of Parma

  STUDY CHAIR

• Andrea Cornini, MD

  Azienda Ospedaliero-Universitaria di Parma, Parma, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 16, 2009
• Study Start: May 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 16, 2009

Record last verified: 2009-06

Locations

IT (2)