Granisetron in Diabetic Parturients Decrease Spinal Induced Hypotension

NCT03091881 | Completed Phase 4

• 1 other identifier: 2978
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic Parturients are exposed to intraoperative hypotension after spinal anesthesia and we proposed that intravenous Granisterone 1 mg will attenuate the hypotension occurred with spinal block during Cesarean sections.

Conditions

Spinal-induced Hypotension

Keywords

Granisetron; Spinal induced hypotension

Outcome Measures

Primary Outcomes (1)

• Total Ephedrine consumption

  Total Ephedrine consumption in mg

  60 minutes after spinal anesthesia

Secondary Outcomes (2)

• Incidence of bradycardia

  60 minutes after spinal anesthesia

• Incidence of hypotension

  60 minutes after spinal anesthesia

Study Arms (2)

Granisetron group

ACTIVE COMPARATOR

patients in this group will receive intravenous Granisetron 0.1 MG/ML 10 minutes before spinal anesthesia

Drug: Granisetron 0.1 MG/ML

Placebo group

PLACEBO COMPARATOR

Patients in this group will receive 10 ml normal saline as placebos considering the same timing and color of solution

Drug: Placebos

Interventions

Granisetron 0.1 MG/ML DRUG

Granisetron 0.1 MG/ML Will be given 10 min before spinal block

Also known as: Granisetron

Granisetron group

Placebos DRUG

Placebos will be given 10 min before spinal block

Also known as: Placebo

Placebo group

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type I diabetic patients
• Parturients presented for Cesarean section

You may not qualify if:

• Contraindications for spinal anesthesia (like bleeding diathesis or regional infection at site of neuroaxial block)
• Known allergy to Granisetron or local anaesthetic (heavy bupivacaine, Marcaine Spinal 0.5% Heavy, 5mg/ml, AstraZeneca ampule)
• Pregnancy induced hypertension
• Congenital or rheumatic heart diseases
• Antepartum haemorrhage
• Fetal destress or gestational age \< 36 week

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University, Faculty of Medicine, Anesthesia and Intensive Care Department

Ismailia, 41522, Egypt

Location

Related Publications (7)

• Butterworth J. Physiology of spinal anesthesia: what are the implications for management? Reg Anesth Pain Med. 1998 Jul-Aug;23(4):370-3; discussion 384-7. doi: 10.1016/s1098-7339(98)90008-6. No abstract available.

  PMID: 9690588 BACKGROUND

• Adams VR, Valley AW. Granisetron: the second serotonin-receptor antagonist. Ann Pharmacother. 1995 Dec;29(12):1240-51. doi: 10.1177/106002809502901211.

  PMID: 8672830 BACKGROUND

• Ziegler D, Dannehl K, Muhlen H, Spuler M, Gries FA. Prevalence of cardiovascular autonomic dysfunction assessed by spectral analysis, vector analysis, and standard tests of heart rate variation and blood pressure responses at various stages of diabetic neuropathy. Diabet Med. 1992 Nov;9(9):806-14. doi: 10.1111/j.1464-5491.1992.tb01898.x.

  PMID: 1473320 BACKGROUND

• Pfeifer MA, Weinberg CR, Cook DL, Reenan A, Halter JB, Ensinck JW, Porte D Jr. Autonomic neural dysfunction in recently diagnosed diabetic subjects. Diabetes Care. 1984 Sep-Oct;7(5):447-53. doi: 10.2337/diacare.7.5.447.

  PMID: 6499637 BACKGROUND

• Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16. doi: 10.1097/00000542-199206000-00006.

  PMID: 1599111 BACKGROUND

• Arndt JO, Bomer W, Krauth J, Marquardt B. Incidence and time course of cardiovascular side effects during spinal anesthesia after prophylactic administration of intravenous fluids or vasoconstrictors. Anesth Analg. 1998 Aug;87(2):347-54. doi: 10.1097/00000539-199808000-00021.

  PMID: 9706929 BACKGROUND

• Rhodes VA, Watson PM, Johnson MH. Development of reliable and valid measures of nausea and vomiting. Cancer Nurs. 1984 Feb;7(1):33-41. No abstract available.

  PMID: 6559094 BACKGROUND

MeSH Terms

Interventions

Granisetron

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mohamed A Elsadany, M.D

  Suez Canal University, Faculty of Medicine, Anesthesia and Intensive Care Department

  STUDY DIRECTOR

• Amr M Helmy, M.D

  Suez Canal University, Faculty of Medicine, Anesthesia and Intensive Care Department

  STUDY DIRECTOR

• Emad E Ahmed, M.D

  Suez Canal University, Faculty of Medicine, Anesthesia and Intensive Care Department

  PRINCIPAL INVESTIGATOR

• Abdelrhman Alshawadfy, M.D

  Suez Canal University, Faculty of Medicine, Anesthesia and Intensive Care Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesiology

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: March 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: November 1, 2018
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)