Nebulized vs. IV Ketamine in Preventing Shivering Post Spinal Anesthesia

NCT ID: NCT07055828

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-02
• Study Completion Date: 2025-07-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group P (Placebo)

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

Group Type: ACTIVE_COMPARATOR

Normal Saline

Intervention Type: DRUG

Patients received Intravenous Normal saline

Saline Inhalants

Intervention Type: DRUG

Patients received nebulized Saline

Group NK (Nebulized Ketamine)

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.

Group Type: ACTIVE_COMPARATOR

Intranasal ketamine

Intervention Type: 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

Normal Saline

Intervention Type: DRUG

Patients received Intravenous Normal saline

Group IVK (Intravenous Ketamine)

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.

Group Type: PLACEBO_COMPARATOR

Ketamine

Intervention Type: DRUG

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

Saline Inhalants

Intervention Type: DRUG

Patients received nebulized Saline

Interventions

Ketamine

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

Intervention Type: DRUG

Intranasal ketamine

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

Intervention Type: DRUG

Normal Saline

Patients received Intravenous Normal saline

Intervention Type: DRUG

Saline Inhalants

Patients received nebulized Saline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who were assigned for Inguinal Hernia hernioplasty;

Exclusion Criteria

• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Lotfy

Assistant Professor of Anesthesia, Pain Management and Surgical ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El Gharbyia, Egypt

Countries

Egypt

Other Identifiers

36264PR1219/5/25

Identifier Type: -

Identifier Source: org_study_id