Nebulized vs. IV Ketamine in Preventing Shivering Post Spinal Anesthesia

NCT07055828 | Active Not Recruiting

• 1 other identifier: 36264PR1219/5/25
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Shivering is an involuntary muscle activity, often triggered by hypothermia, that can occur after anesthesia. This is known as postanesthetic shivering (PAS) and is a common issue that increases oxygen demand, raises the risk of low oxygen levels, and can lead to complications after surgery. Spinal anesthesia (SA) is a popular choice due to its quick action and effective numbing. However, it's frequently linked to shivering during and after the procedure. To combat PAS, various methods have been used. Non-pharmacological approaches like insulation, continuous warming, and temperature management have been shown to reduce low body temperature during surgery and decrease shivering and complications afterward, aiding recovery. Pharmacologically, certain medications can help. Intrathecal meperidine or intravenous (IV) ketamine are effective in preventing PAS. Intrathecal midazolam can also reduce shivering, unlike fentanyl. Additionally, IV ketamine infusion can lower the incidence of low blood pressure and shivering in patients receiving SA. Low-dose ketamine combined with dexmedetomidine, or dexmedetomidine alone, have also shown similar effectiveness in reducing shivering and postoperative nausea and vomiting during SA.

Conditions

Post Spinal Anesthesia Shivering

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Nebulized Ketamine on Post-Anesthesia Shivering (PAS) Incidence and Severity

  This Study asses the effectiveness of the administered therapy in controlling Post-Anesthesia Shivering (PAS) as a reduction in both its incidence and severity. Specifically, effective control is indicated by a Bedside Shivering Assessment Score (BSAS) of less than 2 within the initial 60 minutes post-therapy, alongside a reduction in other associated adverse effects.

  56 days

Study Arms (3)

Group P (Placebo)

ACTIVE COMPARATOR

Patients in this group met the study's inclusion criteria and received inactive solutions (saline) both through nebulization and intravenously, serving as a control.

Drug: Normal Saline; Drug: Saline Inhalants

Group NK (Nebulized Ketamine)

ACTIVE COMPARATOR

Patients in this group met the study's inclusion criteria and received ketamine via a nebulizer at a specific dose. They also received intravenous saline as a placebo.

Drug: Intranasal ketamine; Drug: Normal Saline

Group IVK (Intravenous Ketamine)

PLACEBO COMPARATOR

Patients in this group met the study's inclusion criteria and received ketamine intravenously as a prophylactic drug before spinal anesthesia. They also received nebulized saline as a placebo.

Drug: Ketamine; Drug: Saline Inhalants

Interventions

Ketamine DRUG

Patients received IV ketamine 0.25 mg/kg before Spinal anesthesia as a prophylactic drug

Group IVK (Intravenous Ketamine)

Intranasal ketamine DRUG

Patients received nebulized ketamine at a dose of 0.75 mg/kg adjusted to 5 ml by adding normal saline to be inhaled through a breath-actuated nebulizer

Group NK (Nebulized Ketamine)

Normal Saline DRUG

Patients received Intravenous Normal saline

Group NK (Nebulized Ketamine); Group P (Placebo)

Saline Inhalants DRUG

Patients received nebulized Saline

Group IVK (Intravenous Ketamine); Group P (Placebo)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who were assigned for Inguinal Hernia hernioplasty;

You may not qualify if:

• Patients who were on the American Society of Anesthesiologists Physical Status classification (ASA) grade \>II;
• Patients with body mass index (BMI) \>30 kg/m²;
• Patients with Upper respiratory tract diseases;
• Patients with spinal deformities or diseases;
• Patients with coagulopathy, or allergies to the drugs used;

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El Gharbyia, 13511, Egypt

Location

MeSH Terms

Interventions

Ketamine; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia, Pain Management and Surgical ICU

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 9, 2025
• Study Start: May 2, 2025
• Primary Completion: June 27, 2025
• Study Completion: July 15, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-06

Locations

EG (1)