Comparative Study Between the Prophylactic Intravenous Administrations of Acetaminophen vs Dexamethasone vs Pethidine Regarding the Incidence of Shivering Induced by Single Shot Spinal Anesthesia in the Orthopedic Surgeries of the Lower Limbs

NCT05284409 | Completed Phase 4

• 1 other identifier: ADP
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Single Shot Spinal anesthesia (SSSA) is associated with considerable perioperative shivering and can be challenging to treat. Some pharmacologic agents like N-methyl d-aspartate receptor antagonists, magnesium sulfate and opioid analgesics have been used for restriction of post-spinal anesthesia shivering. Besides that shivering is poorly understood, the gold standard for the treatment and prevention has not been defined yet. This study is to determine the effect of prophylactic intravenous administration of acetaminophen versus dexamethasone versus pethidine in controlling shivering induced by spinal anesthesia

Conditions

Shivering

Outcome Measures

Primary Outcomes (1)

• The incidence of shivering

  The incidence of shivering induced by single shot spinal anesthesia after the prophylactic administration of the study medications. When shivering occurs, it will be graded using Bedside Shivering Assessment Scale (BSAS): 0 - None: No Shivering, 1 - Mild: Shivering localized to neck/thorax, maybe seen only as artifact on ECG or felt by palpation 2 - Moderate: Intermittent involvement of the upper extremities +/- thorax 3 -Severe: Generalized shivering or sustained upper / lower extremity shivering. In all of the groups, the degree of shivering will be assessed at the time of its onset either intra or postoperatively, and throughout the duration of one hour at the post-anesthesia care unit (PACU). Grade 3 or 4 of shivering score will be regarded as failure of prophylaxis, and a rescue dose of 0.2 mg/kg Pethidine IV will be administered and the total dose will be recorded.

  During procedure to up to one hour at the post-anesthesia care unit (PACU)

Secondary Outcomes (5)

• The need to administer pethidine

  The time of administration of pethidine

• the total dose of Pethidine given

  The time of administration of pethidine

• The patient's satisfaction

  up to one hour postoperative

• The level of sedation

  within 5 minutes after the administration of sedative

• Pruritus

  during procedure

Study Arms (3)

Pethidine

ACTIVE COMPARATOR

(control group) 36 patients will receive 0.5 mg/kg Pethidine IVI for management of shivering induced by Single Shot Spinal Anesthesia.

Drug: Pethidine

Acetaminophen

EXPERIMENTAL

36 patients will receive 15 mg/kg Acetaminophen IVI for management of shivering induced by Single Shot Spinal Anesthesia.

Drug: Acetaminophen

Dexamethasone

EXPERIMENTAL

36 patients will receive 0.1 mg/kg Dexamethasone IVI for management of shivering induced by Single Shot Spinal Anesthesia.

Drug: Dexamethasone

Interventions

Pethidine DRUG

36 patients will receive 0.5 mg/kg Pethidine IVI

Pethidine

Acetaminophen DRUG

36 patients will receive 15 mg/kg Acetaminophen IVI

Acetaminophen

Dexamethasone DRUG

36 patients will receive 0.1 mg/kg Dexamethasone IVI

Dexamethasone

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status (ASA) I or II.
• Both sexes.
• Age ranging from 20 to 55 years old.
• Body weight ranging from 60 to 100 kilograms.
• Receiving Single Shot Spinal anesthesia.
• Scheduled for orthopedic surgeries of the lower limb.

You may not qualify if:

• Patient's refusal.
• Allergy to local anesthetics or any of the studied drugs.
• Patients with significant cognitive dysfunction.
• Duration of surgery more than 120 min.
• Patients with hypo- or hyperthyroidism.
• An initial body temperature \>38.0 or \<36.0 degree Celsius.
• Receiving vasodilators, or medications likely to alter thermoregulation.
• Pregnancy.
• Sensory blockade level reaching T4 or higher.
• Obesity (BMI \> 35 kg/m2).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, 1181, Egypt

Location

MeSH Terms

Interventions

Meperidine; Acetaminophen; Dexamethasone

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Galal A Al Kadi, MD

  Professor of Anesthesia

  STUDY DIRECTOR

Study Design

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

Model Details: The assigned medication will be prepared in a color coded 250 ml polypropylene bottle of normal saline. The administration of the assigned infusion will be done by a resident not involved in the study after stabilization of the sensory blockade level over a duration of 15 to 20 minutes, the study drugs will be prepared by the hospital pharmacy and follow-up of the patients will be conducted by the anesthesia residents not involved in any other part of the study. Group A: (control group) 36 patients will receive 0.5 mg/kg Pethidine IVI for management of shivering induced by Single Shot Spinal Anesthesia. Group B: 36 patients will receive 15 mg/kg Acetaminophen IVI for management of shivering induced by Single Shot Spinal Anesthesia. Group C: 36 patients will receive 0.1 mg/kg Dexamethasone IVI for management of shivering induced by Single Shot Spinal Anesthesia.

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 17, 2022
• Study Start: July 1, 2022
• Primary Completion: September 20, 2022
• Study Completion: October 1, 2022
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)