Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia: Randomized Controlled Trial
Shivering is a common and distressing complication occurring in 40% to 60% of women undergoing cesarean section under spinal anesthesia. Beyond causing significant maternal discomfort, shivering markedly increases oxygen consumption and metabolic demand, elevates cardiopulmonary workload, and interferes with clinical monitoring. While intravenous meperidine remains a widely used pharmacological agent for shivering prophylaxis, it carries dose-dependent adverse effects such as nausea, vomiting, sedation, and potential neonatal depression. Intranasal dexmedetomidine provides an alternative needle-free method of administration that rapidly absorbs through the nasal mucosa and reduces shivering without suppressing respiratory drive.
The primary purpose of this randomized controlled trial is to evaluate the efficacy of preoperative intranasal dexmedetomidine in reducing the incidence of intraoperative shivering compared with intravenous meperidine and placebo in women undergoing elective cesarean section under spinal anesthesia.
A total of 99 parturients will be randomly allocated to one of three parallel groups (33 patients per group) using a double-dummy design:
- Group D: Receives intranasal dexmedetomidine (1 mcg/kg) 30 minutes before spinal anesthesia, plus an intravenous saline placebo at spinal induction.
- Group M: Receives intranasal saline placebo 30 minutes before spinal anesthesia, plus intravenous meperidine (0.5 mg/kg) at spinal induction.
- Group C: Receives intranasal saline placebo 30 minutes before spinal anesthesia, plus intravenous saline placebo at spinal induction.
Participants will be monitored throughout the surgical procedure to determine the occurrence of shivering, maternal hemodynamic parameters (heart rate, blood pressure, oxygen saturation), sedation levels using the Richmond Agitation-Sedation Scale (RASS), need for rescue anti-shivering medication, side effects, and neonatal outcomes (Apgar scores and birth weight).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 4
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Female patients aged 18 to 40 years.
- American Society of Anesthesiologists (ASA) physical status II.
- Term singleton pregnancy.
- Scheduled for elective cesarean section under spinal anesthesia.
Exclusion Criteria:
- Refusal to participate.
- Contraindications to spinal anesthesia.
- Nasal pathology preventing intranasal drug administration.
- Known allergy or hypersensitivity to any study medication (dexmedetomidine, meperidine, or bupivacaine).
- Significant cardiac disease.
- Renal or hepatic impairment.
- Preeclampsia, eclampsia, or HELLP syndrome.
- Cesarean section requiring general anesthesia.
- Body mass index (BMI) > 40 kg/m².
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Group D: Intranasal Dexmedetomidine
Participants receive intranasal dexmedetomidine 1 mcg/kg diluted in 2 mL normal saline administered 30 minutes before induction of spinal anesthesia in the pre-anesthesia room, along with an intravenous bolus of 10 mL normal saline 0.9% immediately before spinal injection (double-dummy placebo) (n = 33). |
Administered intranasally at a dose of 1 mcg/kg diluted in 2 mL normal saline 0.9% using a sterile dropper, instilled slowly into each nostril 30 minutes before induction of spinal anesthesia in the pre-anesthesia room. Administered as an identical matching placebo within the double-dummy design: 2 mL intranasally (30 minutes prior to spinal anesthesia) and/or 10 mL as an intravenous bolus (immediately before spinal induction). |
|
Comparatore attivo: Group M: Intravenous Meperidine
Participants receive 2 mL normal saline 0.9% intranasally 30 minutes before induction of spinal anesthesia (double-dummy placebo), along with an intravenous bolus of meperidine 0.5 mg/kg diluted to 10 mL normal saline immediately before spinal injection (n = 33). |
Administered as an identical matching placebo within the double-dummy design: 2 mL intranasally (30 minutes prior to spinal anesthesia) and/or 10 mL as an intravenous bolus (immediately before spinal induction). Administered as an intravenous bolus at a dose of 0.5 mg/kg diluted to a total volume of 10 mL normal saline 0.9% immediately before the induction of spinal anesthesia. |
|
Comparatore placebo: Group C: Placebo Control
Participants receive 2 mL normal saline 0.9% intranasally 30 minutes before induction of spinal anesthesia, along with an intravenous bolus of 10 mL normal saline 0.9% immediately before spinal injection (n = 33). |
Administered as an identical matching placebo within the double-dummy design: 2 mL intranasally (30 minutes prior to spinal anesthesia) and/or 10 mL as an intravenous bolus (immediately before spinal induction). |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With Intraoperative Shivering
Lasso di tempo: Through completion of surgery, up to 2 hours
|
Participants will be assessed for the occurrence of intraoperative shivering using a 5-point scale: Grade 0 = no shivering; Grade 1 = piloerection, peripheral vasoconstriction, or cyanosis; Grade 2 = visible muscle activity confined to one muscle group; Grade 3 = visible muscle activity involving more than one muscle group; Grade 4 = gross muscle activity involving the whole body (scores range from 0 to 4, where 0 indicates no shivering and 4 indicates severe whole-body shivering). Shivering is defined as the occurrence of Grade 1 or higher at any time during the procedure. |
Through completion of surgery, up to 2 hours
|
Collaboratori e investigatori
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Inizio studio (Stimato)
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
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Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Cambiamenti di temperatura corporea
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Ipotermia
- Composti eterociclici, 1-anello
- Composti eterociclici
- Preparati farmaceutici
- Azoli
- Imidazoli
- Piperidine
- Soluzioni cristalloidi
- Soluzioni isotoniche
- Soluzioni
- Acidi, eterociclici
- Acidi isonipecotici
- Dexmedetomidina
- Meperidina
- Soluzione salina
Altri numeri di identificazione dello studio
- Nasal Dex for Shivering in CS
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