Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05284409
Other study ID # ADP
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date July 1, 2022
Est. completion date September 2022

Study information

Verified date September 2022
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pethidine
36 patients will receive 0.5 mg/kg Pethidine IVI
Acetaminophen
36 patients will receive 15 mg/kg Acetaminophen IVI
Dexamethasone
36 patients will receive 0.1 mg/kg Dexamethasone IVI

Locations

Country Name City State
Egypt Ain Shams University Hospitals Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The need to administer pethidine 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. The time of administration of pethidine
Secondary the total dose of Pethidine given 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. The time of administration of pethidine
Secondary The patient's satisfaction Patient's satisfaction will be assessed by asking the patient to answer the question, "How would you rate your experience after the operation?" using a 7-point Likert verbal rating scale, and acceptable satisfaction score of the patient will range from 5 to 7 (1 - Extremely dissatisfied, 2 - Dissatisfied, 3 - Somewhat dissatisfied, 4 - Undecided, 5 - Somewhat satisfied, 6 - Satisfied, 7 - Extremely satisfied). up to one hour postoperative
Secondary The level of sedation The level of sedation will be assessed according to a five-point range: [1] alert and oriented, [2] somnolent, [3] closed eyes, arousable on a verbal order, [4] closed eyes, arousable to physical stimuli and [5] closed eyes and patient unarousable to physical stimuli. within 5 minutes after the administration of sedative
Secondary Pruritus Severity of pruritus. Pruritus will be assessed by a four-point ordinal scale where zero points to no itching, one points to mild itching, two points to moderate itching, treatment not requested, three points to severe itching, treatment requested. during procedure
See also
  Status Clinical Trial Phase
Recruiting NCT04730609 - Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery Phase 4
Completed NCT02141412 - Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia Phase 4
Not yet recruiting NCT06283771 - The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering N/A
Completed NCT02436174 - Assessment Of Shivering With iSeismograph N/A
Completed NCT03302351 - Dexmedetomidine, Ketamine and Dexmetedomidine-Ketamine Combination for Control of Shivering During Regional Anaethesia Phase 4
Completed NCT03721432 - The Effect of Oral Pregabalin on Epidural-induced Shivering and Epidural Characteristics N/A
Not yet recruiting NCT03530007 - Anti-shivering Effect of Ondansetron Phase 2/Phase 3
Completed NCT03679052 - Prophylactic Mirtazapine or Clonidine for Post-spinal Anesthesia Shivering Phase 4
Completed NCT03679065 - Prophylactic Paracetamol or Dexamethasone for Post-spinal Anesthesia Shivering Phase 4
Completed NCT03675555 - Prophylactic Mirtazapine or Dexamethasone for Post-spinal Anesthesia Shivering Phase 4
Recruiting NCT04938219 - Shivering_Basel_Baden N/A
Recruiting NCT03157648 - Relationship Between Core-peripheral Temperature Difference and Shivering Symptom in Patients in PACU N/A
Terminated NCT03497507 - Investigating the Effect of Acupressure on Shivering During a Cesarean Delivery in Women Who Were Previously Laboring With an Epidural N/A
Completed NCT03370562 - Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering N/A
Completed NCT05110469 - Comparison of MgSO4 Versus Meperidine for Prevention of Shivering During Spinal Anesthesia Phase 4
Not yet recruiting NCT03566628 - Post-anaesthetic Shivering Amongst Patients Undergoing Cerebral Angiography N/A
Completed NCT02967601 - Influence of Preoperative Anxiety on Shivering During Elective Caesarean Section Under Spinal Anaesthesia N/A
Recruiting NCT05765162 - Safe Brain Initiative, Operationalizing Precision Anaesthesia
Recruiting NCT04870541 - Nefopam Versus Ondansteron for Prevention of Post Spinal Shivering. Phase 4
Active, not recruiting NCT01669213 - Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension N/A