- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07784556
THIS STUDY AIMS TO COMPARE TWO DRUGS KETAMINE AND TRAMAL IN PREVENTION OF SHIVERING IN PATIENTS UNDERGOING SPINAL ANESTHESIA STUDY POPULATION IS PT UNDERGOING C SECTION . DOSE OF KETAMINE IS 0.25mg/kg and That of TRAMAL 0.5mg/kg.
COMPARISON BETWEEN KETAMINE AND TRAMAL IN PREVENTION OF SHIVERING IN PATIENTS UNDERGOING C SECTION UNDER SPINAL ANESTHESIA
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This randomized controlled clinical trial was conducted at Khan Research Laboratory Hospital, Islamabad, from August 2024 to January 2025 after obtaining ethical approval. The objective was to compare the efficacy of intravenous ketamine and intravenous tramadol in preventing shivering among women undergoing elective caesarean section under spinal anaesthesia.
A total of 70 pregnant women aged between 18 and 45 years with ASA physical status II or III and a body mass index between 18 and 35 kg/m² were included after obtaining written informed consent. Patients with contraindications to spinal anaesthesia, significant medical comorbidities, allergy to study drugs, obstetric emergencies, pre-existing bradycardia, hypotension, or refusal to undergo spinal anaesthesia were excluded.
Participants were randomly allocated into two equal groups using a coin-flip randomization method. Standard perioperative preparation and monitoring were performed for all patients. Spinal anaesthesia was administered using hyperbaric bupivacaine through a standard spinal technique. Immediately after delivery of the baby, patients received either intravenous tramadol (0.5 mg/kg) or intravenous ketamine (0.25 mg/kg) according to their assigned study group.
Patients were monitored throughout surgery for the occurrence of shivering using the bedside shivering assessment score. The primary endpoint was efficacy, defined as complete absence of shivering until completion of surgery and wound closure. Secondary outcome measures included the incidence of shivering, onset time of shivering after spinal anaesthesia, and subgroup analyses according to age, BMI, and ASA physical status.
Data were analysed using SPSS version 30. Quantitative variables were summarized using median and interquartile range because data were not normally distributed. Qualitative variables were expressed as frequencies and percentages. Group comparisons were performed using the Chi-square test, Fisher's exact test, and Mann-Whitney U test where appropriate. A p-value of ≤0.05 was considered statistically significant.
The baseline demographic characteristics were comparable between the two groups with respect to age, BMI, and ASA status. The incidence of post-spinal anaesthesia shivering was significantly lower in the ketamine group than in the tramadol group. Patients receiving ketamine demonstrated a substantially higher proportion of successful prevention of shivering compared with those receiving tramadol. Furthermore, the onset of shivering was delayed or absent in most patients receiving ketamine. Stratified analyses according to age, BMI, and ASA classification did not demonstrate any significant influence of these variables on treatment efficacy.
The study findings indicate that prophylactic low-dose intravenous ketamine provides superior protection against post-spinal anaesthesia shivering compared with low-dose intravenous tramadol in women undergoing caesarean section under spinal anaesthesia. These results support the use of ketamine as an effective prophylactic agent for reducing intraoperative shivering in obstetric patients and may contribute to improved maternal comfort.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
Islamabad
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Islamabad, Islamabad, Pakistan, 44000
- KRL Hospital Islamabad
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Punjab Province
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Rawalpindi, Punjab Province, Pakistan, 46000
- KRL Hospital Islamabad
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
ASA-2 and ASA-3 patients Undergoing Elective C-Section
Exclusion Criteria:
ASA-4 and above Emergency C-Section Cases
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Tramadol Group
Participants received intravenous tramadol 0.5 mg/kg immediately after delivery of the baby to prevent post-spinal anesthesia shivering.
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Single IV dose of tramadol 0.5 mg/kg given immediately after delivery.
|
|
Experimental: Ketamine Group
Participants received intravenous ketamine 0.25 mg/kg immediately after delivery of the baby to prevent post-spinal anesthesia shivering.
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Single intravenous dose of ketamine 0.25 mg/kg administered immediately after delivery of the baby during elective caesarean section under spinal anaesthesia for prevention of post-spinal shivering.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of Post-Spinal Anesthesia Shivering
Zeitfenster: Within 30 minutes of spinal anesthesia administration
|
Proportion of patients who developed shivering after spinal anesthesia, graded using the Tsai and Chu shivering scale (0 = no shivering; 1 = piloerection; 2 = visible tremors in one muscle group; 3 = visible tremors in more than one muscle group; 4 = gross tremors of the whole body).
|
Within 30 minutes of spinal anesthesia administration
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Severity of Post-Spinal Anesthesia Shivering
Zeitfenster: Within 30 minutes of spinal anesthesia administration
|
Severity of shivering graded using the Tsai and Chu scale (0-4) in patients who developed shivering after spinal anesthesia.
|
Within 30 minutes of spinal anesthesia administration
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Amna Raza, MBBS FCPS, KRL Hospital, Islamabad
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Compbketandtramal123
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