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The effeect of intravenous injection of midazolam ,midazolam- ketamine and ketamine on reduce prevalence of post spainal sheivering

The effeect of intravenous injection of midazolam ,midazolam- ketamine and ketamine on reduce prevalence of post spainal sheivering in patients undergoing elective cesarean section

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016043012251N3
Enrollment
124
Registered
2016-05-21
Start date
2016-06-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post spainal sheivering. Other complications of anaesthesia

Interventions

Intervention 1: In First group, we will inject 75 µg /kg of Midazolam IV. after clamping the umbilical cord. Intervention 2: In Second group, we will inject 0/5mg / kg of ketamine IV. after clamping t
Prevention
Placebo
In First group, we will inject 75 µg /kg of Midazolam IV. after clamping the umbilical cord.
In Second group, we will inject 0/5mg / kg of ketamine IV. after clamping the umbilical cord.
In Third group, we will inject 0/25mg / kg of ketamine and 37/5µg / kg midazolam IV. after clamping the umbilical cord.
In control group we will inject 2 cc of Normal saline 0/9% IV. after clamping the umbilical cord

Sponsors

Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: (a) Age 18-40 years and undergoing cesarean section; (b) ; physical status class I or II in accordance with anesthesia; (c) Term pregnancy (gestational age 36-40 weeks); (d) Singleton pregnancy. Exclusion criteria: (a) High-risk pregnancy; (b) Preeclampsia;(c) A history of cardiovascular disease, lung disease, mental, thyroid disease, diabetes mellitus type 1 and 2;(d) needs to blood or blood supply transfusion;(e) Fever over 38 ° C;(f) Drag over an hour during surgery;(g) A history of nausea and vomiting to Previous surgery;(h) Despite the decrease in body temperature or sheivering before the start of anesthesia due to fear or other reasons;(i) Patients with spinal anesthesia ban.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Shivering after spinal anesthesia in patients undergoing elective cesarean. Timepoint: Since spinal anesthesia or intravenous of midazolam, ketamine ,midazolam- ketamine or normal saline. Method of measurement: Shivering intensity divided by 4 score will be assessed.Grade zero: no Shivering . Grade1: mild fasciculation in the face and neck. Grade2: trembling visible muscle groups in more than one category. Grade 3: Zlany activity of the whole body is involved.

Secondary

MeasureTime frame
Heart rate. Timepoint: during the surgery and recovery. Method of measurement: Cardiac monitor.;Arterial blood oxygen saturation. Timepoint: during the surgery and recovery. Method of measurement: Pulse oximeter.;Hemodynamic instability. Timepoint: during the surgery and recovery. Method of measurement: Sphygmomanometer.;Hallucination. Timepoint: during the surgery and recovery. Method of measurement: Observation.;Sedation Score. Timepoint: during the surgery and recovery. Method of measurement: Ramsay score.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasim Alipour

Fatemieh Hospital

n.alipour@umsha.ac.ir+98 31 3827 7012

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026