Comparison of Ketamine Plus Dexamethasone Versus Ketamine Alone for Prevention of Severe Shivering After Spinal Anesthesia in Cesarean Section

NCT06091657 | Completed

• 1 other identifier: MS-525-2023
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Shivering is one of the most distressing events of the birth experience for patients. Shivering that occurs with spinal anesthesia is a frequent event, with a reported incidence of up to 50-65%. (1) This may be normal thermoregulatory shivering in response to core hypothermia or may result from the release of cytokines by the surgical procedure. (2-4) shivering is graded with a scale described by Bedside Shivering Assessment Score (BSAS). (3, 4) Most of the literature recommends a variety of non-pharmacological and pharmacological options for the prevention and treatment of shivering after spinal anesthesia. Pethidine, tramadol, clonidine, dexmedetomidine, biogenic amines (serotonin 5-HT3 receptor antagonist), low-dose ketamine, dexamethasone, and magnesium sulfate were used as pharmacological agents. (5) Intravenous (IV) ketamine 0.25 mg/kg was approved as effective in the prevention and treatment of shivering after regional anesthesia and can be used in patients undergoing cesarean sections without adverse effects on the baby. (5) Ketamine is a competitive N-methyl-D-aspartate receptor antagonist, and it is believed that its anti-shivering action is due to non-shivering thermogenesis, either by effect on the hypothalamus or by the β-adrenergic effect of norepinephrine. (6) In spite of the approved effectiveness of ketamine in this issue, moderate to severe shivering (grade ≥ 2) still occurs with an incidence that cannot be ignored. (7-9) Dexamethasone was also approved as an alternative pharmacological agent for the prevention and treatment of mild and moderate shivering. (10) Dexamethasone prevents shivering by regulating immune response and decreasing the temperature gradient between skin and body core via its anti-inflammatory action and inhibition of the release of vasoconstrictors and pyrogenic cytokines. We hypothesize that addition of dexamethasone (0.1 mg\\kg) to low dose ketamine (0.25 mg\\kg) will be more effective in prevention of severe shivering after spinal anesthesia with cesarean section with minimal sedation of the mother and negligible effect on the baby. This can be applicable in resource-limited settings.

Conditions

Intraoperative Shivering; Ketamine With Shivering; Dexamethasone for Shivering; Severe Shivering

Keywords

shivering; ketamine; dexamethasone

Outcome Measures

Primary Outcomes (1)

• number of shivering episodes

  ● the number of shivering episodes scored ≥3 will be recorded.

  the whole procedure and for 60 minutes postoperative

Secondary Outcomes (3)

• sedation score of the mother

  120 minutes

• APGAR score of the baby

  5 minutes

• hemodynamics

  120 minutes

Study Arms (2)

ketamine group

ACTIVE COMPARATOR

Group K (ketamine): syringe (1): the ketamine syringe, dilute 25 mg ketamine in 10 ml saline to have a concentration of 2.5mg/ml. The dose will be 0.25 mg/kg, so we will give 0.1ml/kg of the syringe. syringe (2): saline syringe 10 ml saline in 10 ml syringe. (for double blinded technique). we will give 0.1ml/kg of the syringe.

Drug: Ketamine Hydrochloride

ketamine dexamethasone group

ACTIVE COMPARATOR

Group KD (ketamine plus dexamethasone): Syringes (1): the ketamine syringe, dilute 25 mg ketamine in 10 ml saline to have a concentration of 2.5mg/ml. The dose will be 0.25 mg/kg, so we will give 0.1ml/kg of the syringe. Syringe (2): dexamethasone syringe, 10 mg dexamethasone will be diluted with 10 ml saline in 10 ml syringe, concentration will be 1mg/ml. the dose will be 0.1 mg/kg, so we will give 0.1ml/kg of the syringe.

Drug: Ketamine Hydrochloride

Interventions

Ketamine Hydrochloride DRUG

intravenous injection

Also known as: dexamethasone

ketamine dexamethasone group; ketamine group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant females
• aged 18 to 45 years
• ASA physical status II
• elective Cesarean sections under spinal anesthesia

You may not qualify if:

• Contraindications for spinal anesthesia
• Emergency cesarean sections
• Patient with initial body temperature \>38°c or \<36°c
• Allergy to any of the drugs used in the study
• Pre Existing neurological diseases (particularly those that wax and wane, e.g.multiple sclerosis)
• Thrombocytopenia and coagulation disorders.
• Severe stenotic heart disease.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Al Aini Hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Ketamine; Dexamethasone

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia& ICU

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 19, 2023
• Study Start: January 1, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 30, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

EG (1)