To compare the pain relieving effect of ketamine versus magnesium sulphate as add-on to bupivacaine given in spinal anaesthesia for caesarean section

Comparison of analgesic efficacy of ketamine versus magnesium sulphate as adjuvant to intrathecal bupivacaine in parturients undergoing elective caesarean section – a randomised interventional study at SMS Medical College & attached group of hospital, Jaipur

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059277

Enrollment

Registered

2023-10-30

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

None listed

Interventions

Intervention1: Adding ketamine as an adjuvant to intrathecal bupivacaine at the time of spinal anaesthesia at 0 minutes: Spinal anaesthesia with 0.5% hyperbaric bupivacaine 1.8 ml (9 mg) with preserva

Eligibility

Inclusion criteria

Inclusion criteria: patients going for elective caesarean section under spinal anaesthesia.Patients who will give informed written consent in vernacular language.Belonging to ASA Classes II status.Height of the parturient 145–170 cm.

Exclusion criteria

Exclusion criteria: Patients with systemic diseases.Patients with body mass index >38kg/cm2.Patients having history of preeclampsia and eclampsia,fetal distress. Patients having allergy to study drug.Patients having contraindications to spinal anaesthesia. • Patients consuming tranquilizers, hypnotics, sedatives.

Design outcomes

Primary

Measure	Time frame
1. To assess & compare between two groups the mean duration of analgesia. 2. To determine difference in mean time duration of sensory onset of spinal anaesthesia between bupivacaine & ketamine versus bupivacaine and magnesium sulphate in parturients undergoing elective caesarean section using pin prick method. 3. To assess and compare between two groups the mean time duration in motor onset using bromage score. 4. To assess and compare between two groups the mean time duration for sensory regression using pin prick sensation. 5. To assess and compare between two groups the mean time duration for motor regression using bromage scale.Timepoint: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.	—

Measure

Time frame

1. To assess & compare between two groups the mean duration of analgesia. 2. To determine difference in mean time duration of sensory onset of spinal anaesthesia between bupivacaine & ketamine versus bupivacaine and magnesium sulphate in parturients undergoing elective caesarean section using pin prick method. 3. To assess and compare between two groups the mean time duration in motor onset using bromage score. 4. To assess and compare between two groups the mean time duration for sensory regression using pin prick sensation. 5. To assess and compare between two groups the mean time duration for motor regression using bromage scale.Timepoint: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.

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Secondary

Measure	Time frame
1. To assess & compare hemodynamic changes between the two groups. 2. Study any adverse effects associated with drugs given.Timepoint: 0 minutes 5 minutes 10 minutes 15 minutes 30 minutes 45 minutes	—

Countries

India

Contacts

Public ContactNavdeep Kumar Mansinghka

Sawai Man Singh Medical College

rupihar@gmail.com9899785993

Outcome results