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IRCT20260225068946N1 IRCT 2026-07-30 Superior university lahore Comparison of Three Different Doses of Dexmedetomidine Added to Spinal Anesthesia for Elective Caesarean Section DDB-CS Trial Effects of Three Different Doses of Intrathecal Dexmedetomidine Added to Bupivacaine on effectiveness of Subarachnoid Block in Elective Caesarean Sections: A Prospective Randomized Double-Blind Study 2026-08-12 anticipated 160 Recruiting https://irct.ir/trial/89284 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Prospective, randomized, double-blind, parallel-group, controlled clinical trial with four intervention arms comparing three doses (5 µg, 7.5 µg, and 10 µg) of intrathecal dexmedetomidine added to hyperbaric bupivacaine with a control group receiving hyperbaric bupivacaine alone, Randomization description: Participants were randomly assigned to one of four study groups using computer-generated block randomization with a 1:1:1:1 allocation ratio. The randomization sequence was prepared by an independent investigator, and group assignments were concealed in sequentially numbered, opaque, sealed envelopes until participant enrollment, Blinding description: Participants and outcome assessors were blinded to group allocation. The intrathecal study drug was prepared by an independent anesthetist not involved in patient management or outcome assessment. All study solutions had identical appearance and volume, ensuring that participants and the anesthesiologist administering the drug remained unaware of treatment allocation until completion of data collection. 4 Obstetric patients undergoing elective cesarean section under spinal anesthesia. Intervention 1: Control group: (Intrathecal hyperbaric bupivacaine 10 mg with placebo (normal saline). Intervention 2: Intervention group: (Intrathecal hyperbaric bupivacaine 10 mg + dexmedetomidine 5 µg). Intervention 3: Intervention group: (Intrathecal hyperbaric bupivacaine 10 mg + dexmedetomidine 7 µg). Intervention 4: Intervention group: (Intrathecal hyperbaric bupivacaine 10 mg + dexmedetomidine 10 µg). Yes - There is a plan to make this available What will be shared: De-identified Clinical Trial Dataset and Study Documents” Details: “The dataset will include anonymized demographic characteristics, clinical observations, sensory and motor block parameters, duration of analgesia, hemodynamic measurements, adverse effects, sedation scores, and neonatal Apgar scores collected during the study. Additional documents may include the study protocol, statistical analysis plan, and final study results. All shared data will be de-identified to protect participant confidentiality When: The data will become available after completion of the study, final data analysis, and publication of the results. The data may be available for a period of 5 years after publication upon reasonable request and approval from the principal investigator To whom: The data/documents will be available to qualified researchers, academic institutions, and scientific reviewers upon reasonable request and approval from the principal investigator and relevant ethical authorities. Access will be provided only for legitimate research purposes while maintaining participant confidentiality. Conditions: The data/documents may be used for scientific research, academic purposes, systematic reviews, and secondary analyses related to obstetric anesthesia, spinal anesthesia, and intrathecal dexmedetomidine. Requests will be evaluated based on scientific merit, ethical approval (if required), and assurance of maintaining participant confidentiality.” Where to obtain: The data/documents can be obtained from the principal investigator of the study upon reasonable request. Access will be provided after review and approval of the request, in accordance with ethical requirements and data confidentiality policies. How to obtain: A formal request should be submitted to the principal investigator describing the purpose of data use. The request will be reviewed for scientific validity, ethical compliance, and confidentiality requirements. After approval, de-identified data/documents will be shared through a secure method with the requester Comments: No additional comments. All shared data and documents will be de-identified to ensure participant confidentiality and will be made available only for legitimate scientific and academic purposes following ethical approval and the consent of the principal investigator.
public haider zaman
Jarbat, Julagram tehsil batkhela
Batkhela Pakistan 23020 +92 343 1952928 haiderzaman311@gmail.com Superior university lahore scientific Haider Zaman
Post office dehri julagram tehsil batkhela district malakand kpk pakistan
Batkhela malakand Pakistan 23020 +92 343 1952928 haiderzaman311@gmail.com Health department Khyber pakhtunkhwa Pakistan Female patients aged 18–40 years. ASA physical status I or II. Scheduled for elective caesarean section under spinal anaesthesia Willing to provide informed consent 18 years 40 years Female Emergency caesarean sections. Known fatal anomalies. Contraindications to spinal anaesthesia (e.g., infection at puncture site, coagulopathy). Known allergy to dexmedetomidine or bupivacaine. Significant maternal medical conditions (cardiovascular, neurological, hepatic, or renal disorders). Placebo Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: (Intrathecal hyperbaric bupivacaine 10 mg with placebo (normal saline) Intervention group: (Intrathecal hyperbaric bupivacaine 10 mg + dexmedetomidine 5 µg) Intervention group: (Intrathecal hyperbaric bupivacaine 10 mg + dexmedetomidine 7 µg) Intervention group: (Intrathecal hyperbaric bupivacaine 10 mg + dexmedetomidine 10 µg) Onset and duration of sensory block, onset and duration of motor block, and duration of postoperative analgesia following spinal anesthesia. Timepoint: Assessment will be performed from the time of spinal anesthesia administration until 24 hours after surgery. Method of measurement: Sensory block will be assessed using the pinprick method and motor block using the Modified Bromage scale. Duration of analgesia will be measured from the time of spinal anesthesia administration until the first request for rescue analgesia. Hemodynamic changes (heart rate and blood pressure), incidence of adverse effects including hypotension, bradycardia, nausea, vomiting, shivering, and sedation level will be assessed. Neonatal outcomes will be evaluated using Apgar scores at 1 and 5 minutes. Timepoint: During the intraoperative period and within the first 24 hours after surgery. Method of measurement: Heart rate and blood pressure will be recorded using standard non-invasive monitoring. Adverse effects including hypotension, bradycardia, nausea, vomiting, and shivering will be documented. Sedation will be assessed using the Ramsay Sedation Scale. Neonatal condition will be evaluated using Apgar scores at 1 and 5 minutes after birth. Superior university lahore Approved 2025-10-10 Ethics committee of superior university Jarbat, Julagram tehsil batkhela, district malakand kpk Pakistan Batkhela Khyber Pakhtunkhwa Pakistan